513 results
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25ms
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Sources: EU EUDAMED, US FDA
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CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20" (1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHM·May 20, 2014
LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100% COTTON ( 1) TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7" CUFF 30" X 42" ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. ( 1) BOWL PLASTIC 80oz ( 1) LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4" X 4" 16PLY (2) PAD OBSTETRICAL X-LARGE ST. ( 1) PACKING VAGINAL XRD 4 X 36 8PLY ( 1) TABLE COVER REINFORCED 50" X 90" ( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1 ) NEEDLE HYPODERMIC 21G X 1% ST. (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) PVP SCRUB 8" STICK SPONGES ST. ( 1) EAR ULCER SYRINGE 2oz. ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (2) WRAPPER 30" X 30" ( 1) PVP PAINT 8" STICK SPONGE ST. (2) GLOVE SURG DERMA PRENE #7 % PF (1) TIME OUT BEACON NON WOVEN ST. (1) VACUTAINER GREEN NAHEP 10ML EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·May 20, 2014
ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF (2) UTILITY BOWL 32oz LIF (1) EMESIS BASIN 101N 700cc (4) TOWEL CLAMP (3) TOWELS ABSORBENT 15" x 20" LIF (1) MOSQUITO HALSTED (2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE (1) SCALPEL SAFETY #11 (3) LABELS FOR SKIN MARKER (1) LABEL F/MED. SALINE NORMAL BLUE (1) NEEDLE HYPODERMIC 18G X 1 Y2 (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz (4) BAND BAG WITH RUBBAND & TAPE LIF (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH (1) NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE (2) NEEDLE HYPODERMIC 23GA X 1" (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014
ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014
C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DRAPE SHEET 41" X 69" MEDIUM LIF (2) SURGICAL BLADE #10 CARBON STEEL (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CONTAINER 64oz WITH LID (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) MAYO STAND COVER REINFORCED UF (1) BAG SUTURE FLORAL (15) LAP SPONGES PRE-WASH XRD LIF (1) EAR ULCER SYRINGE 2oz UF (1) CORD UMBILICAL CLAMP L/F (1) WASH BASIN ?QT. (1) CAUTERY TIP POLISHER LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) FEEDING TUBE 8FR. 15" LONG (4) DRAPE UTILITY WITH TAPE UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHM·May 20, 2014
OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) RECEIVING BLANKET 100% COTTON (1) PVP SCRUB 8" STICK SPONGE (1) FEEDING TUBE BFR, 15" LONG LIF (1) BOWL PLASTIC 80oz WITH LID (1) CORD UMBILICAL CLAMP (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 20cc SLIP TIP LIF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) NEEDLE HYPODERMIC 22G X 1% (20) GAUZE SPONGE 4" X 4" 16PL Y (1) EAR ULCER SYRINGE 2oz LIF (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF (2) GLOVE MED FREETOUCH VYNIL POWDER FREE (1) WRAPPER 24" X 24" L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·May 20, 2014
CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST. (1) SYRINGE 20cc W/0 NEEDLE LIL (1) SYRINGE EAR/ULCER 2oz. (1) BLANKET RECEIVING 100% COTION (1) CLAMP UMBILICAL CORD ST. (1) COVER TABLE REINFORCED 50" X 90" (1) SYRINGE 10CC W/0 NEEDLE L/LOCK (1) BOWL PLASTIC W/LID 80oz (2) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET DRAPE 41" X 58" SMS (1) DRAPE C SECTION W/POUCH 102" X 121" X 78" (1) YANKAUER SUCTION TUBE W/0 VENT (1) WRAPPER 30" X 30" (15) SPONGE LAP PREWASH 18" X 18" XRD (1) TIME OUT BEACON NON WOVEN ST. (1) TUBE SUCTION CO NN ECT~" X 12' (2) LIGHT SHIELD (1) GOWN SURG REINF LARGE T/WRAP (2) PK. STRIP STERI CLOSURE W' X 4" (1) POLISHER CAUTERY TIP (1) DRESSING COMP OP 4" X 14" (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHM·May 20, 2014
ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F (1) HALSTED MOSQUITO (1) PVP SCRUB 8" STICK SPONGE (1) TRAY PLATFORM LARGE (3) LABELS FOR SKIN MARKERR (1) LABEL FOR MEDICATION SALINE NORMAL BLUE (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) NEEDLE HYPODERMIC 18G X 1 'h (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (2) UTILITY BOWL 16oz (3) BAND BAG WITH RUBBAND & TAPE LIF (25) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) DRAPE ANGlO 75" X 145" (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF (1) SAFETY SCALPEL #11 LIF (1) GOWN STANDARD SMS LARGE VELCRO NECK (2) NEEDLE HYPODERMIC 23G X 1" (1) TRAY ORGANIZER FULL DEEP (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) LABEL FOR MEDICATION INTEGRILIN RED (1) PVP PAINT 8" STICK SPONGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014
NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) Pr. SURGICAL GLOVES 7 Y2 (2) Pr. SURGICAL GLOVES 8 (2) EAR ULCER SYRINGE 2oz LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) SHEET MINOR LAP 102" X 121" X 78" (1) SAFETY SCALPEL #10 (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (4) CLOTH HUCK TOWELS BLUE (1) PENCIL CAUTERY ROCKER SWITCH (2) LEGGINS W/7'' CUFF 30" X 42" (1) DRAPE% ECONOMY 53" X 77" LIF (1) Pk. SURGICAL STRIP 'X" X 6" (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (2) ROUND WASH BASIN 6QT (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE (2) Pr. SURGICAL GLOVES 7 (1) SKIN MARKER WITH RULER LIF (1) Pk. STERI STRIP CLOSURE %"X 4" LIF (1) TUBE SUCTION CONNECT. 'X" X 12' LIF (1) SAFETY SCALPEL #15 (1) SAFETY SCALPEL #11L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJG·May 20, 2014
CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41 " X 58" SMS LIF (5) TOWEL ABSORBENT 15" X 20" LIF (15) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) SYRINGE EAR/ULCER 2oz. L/F (1) BLANKET BABY PRINTED (1) TUBE SUCTION CONNECT Y-1" X 12' LIF (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) BLANKET RECEIVING 100% COTTON (1) BOWL W/LID PLASTIC 80oz. (1) UMBILICAL CORD CLAMP (1) TUBE FEEDING PVC 8FR 15" LONG (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BAG SUTURE FLORAL (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE (1) SCALPEL W/HANDLE #1 0 (1) SCALPEL W/HANDLE #20 (2) BOWL UTILITY 16oz. LIF (1) PVP PAINT 8" STICK SPONGE LIF (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) SCISSOR UMBILICAL 4.5" STRAIGHT (1) WRAPPER 24" X 24" LIF (1) PVP SCRUB 8" STICK SPONGE LIF (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF (1) TIME OUT BEACON NON WOVEN LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHM·May 20, 2014
FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1 06" LONG LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF (2) MEDICINE CUP 2oz. CLEAR LIF (1) SCALPEL WEIGHTED SAFETY #11 (2) CHLORASCRUB SWABSTICK 5.1 ML LIF (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) FORCEP ADS ON TISS. WITH TIP LIF (1) UTILITY BOWL 32oz LIF (1) UTILITY BOWL 16oz L/F (1) FORCEP KELLY STRAIGHT 5.5" LIF (1) MOSQUITO HALSTED CVD 5" LIF (1) TRAY ORGANIZER FULL DEEP LIF (1) SCISSOR MAYO 6.75 STRAIGHT LIF (1) HOLDER NEEDLE WEBSTER 4.75 LIF (1) GUIDEWIRE .035" X 150cm UF (1) TIME OUT BEACON NON WOVEN ST. UF (1) MAYO TRAY SMALL LIF (2) TOWEL CLAMP UF (2) BAG BAND RUBBAND & TAPE LIF (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF LABEL SAMPLE (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE 18G X 2 o/.i AMC/4 (1) SKIN MARKER INK WITH/8 LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15" X 20" UF (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE o/.. 60" X 76" REINFORCED LIF (1)DRAPE THYROID 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13" X 13" (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. W X 12' LIF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL 16oz LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN MARKER W/RULER LIF (9) LABELS FOR SKIN MARKERS 1.25 X Y:! (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF (1) NEEDLE 30G X 1 DISP. L/F (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF (2) BLADE SURGICAL# 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN LIF (2) TAPE TEGADERM 2 3/8 "X 2 o/.. "L/F (2) MEDICINE CUP 2oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJG·May 20, 2014
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE% 60" X 76" REINFORCED L/F (1) DRAPE CHEST 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. Y." X 12' UF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF (1) STERI STRIP DRAPE LARGE 17" X 23" LIF (1) SKIN MARKER WITH RULER UF (9) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (4) NEEDLE HYPODERMIC 18G X 1Y2 UF (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE SPINAL 18G X 6" LONG LENGTH LIF (1) BLADE SURGICAL # 10 CARBON STEEL (1) BLADE SURGICAL # 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN UF (2) DRESSING TEGADERM 4" X 4% "UF (2) MEDICINE CUP 2oz (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23" X 23" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014
EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P CLOSURE 'h" X 4" ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK (2) SYRINGE I ML WITHOUT NEEDLE LILOCK (I) CAUTERY TIP POLISHER (I) SHEET ENT SPLIT 110" X 77" SMS ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V (2) LITE GLOVE (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT W' X 1 2' (I) EAR ULCER SYRINGE 2oz (I) TABLE COYER REINFORCED 50" X 90" ( I) UTILITY BOWL 16oz (4) APPLICATOR COTTON 6" WOOD (2) STRJPS TAPE 24" X 4" ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK ( I ) MAYOTRAY SMALL ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 ( I ) TI ME OUT BEACON NON WOVEN (I) BLADE M IN IATURE CARBON STEEL (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD (I) SK I N MARKER INK W/8 LABEL (2) NEEDLE HYPODERM I C 27G X I W' ONE PACK WET SK IN W ITH CONTENTS: ( I ) WRAPPER SMS 30" X 30" (2) COTTON TIP APPLICATOR 6" WOOD (2) GLOVE MED FREETOUCH VYNIL P/F (6) SPONGE W ING SMALL (4) TOWELS ABSORBENT 1 5" X 20" (3) TIP ABSORB. APPLICATOR STI CK SPONGE ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE (I) PVP SCRUB SOLUTION 4oz. BOTTLE (I) TRAY 3/COMPARTMENT Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OGR·May 20, 2014
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB 22x 1.5 1 Spike Bag decanter 6 Syringe 10cc L/L 10 Towel or Blue 2 Bag Band 36 X 50 W/TP 1 Prep Ultra Sound Gel Packet 1 Bowl Denture Cup 8 oz (250C 1 Bowl 32 oz (1000CC) 1 Cover Set UP 54X90 1 Instr Forcep Kelly Strt 5.5 1 Angio Tubing HP 10 W/ROT M/L 1 Needle Introducer 21G 1 Dressing Telfa 3X4 2 Syringe 20cC L/L 1 Guidewire Nitinol .018X45CM 1 Drape Angio 80 X 125 W/2 WIN 1 Introducer 5F X 10CM Stiff.
FDA Recall
Terminated
·Windstone Medical Packaging, Inc.·Product code KDD·April 8, 2021
EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OGR·May 20, 2014
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 12KPES SIZE: 12Fr Product No: AAM 8012KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 12KPES Product No: AAM 8012KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 10KPES SIZE: 10Fr Product No: AAM 8010KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 10KPES Product No: AAM 8010KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 8KPES SIZE: 8Fr Product No: AAM 8008KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 8KPES Product No: AAM 8008KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 14KPES Product No: AAM 8014KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011