5 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL (1) MAYO STAND COVER REINFORCED LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 14" X 48" L/F (1) SHEET SPLIT WITH ADHESIVE 1 08" X 77" STD SMS LIF (1) TOP DRAPE WITH ADHESIVE 1 08" X 50" STD SMS L/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
TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk 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 LRO·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
NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT ( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) BULB SYRINGE 60cc LIF (2) NEEDLE & BLADE COUNTER, IOC M/CLEAR LIF (2) PVP SCRUB 8'' STICK SPONGE ST. (I)SKIN STAPLE 35 WIDE ST. LIF (2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF (2) LITE GLOVE (I) TABLE COYER BTC 79" X 110" HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W' X 1 2' LIF (4) DRAPE UTILI TY WIT APE LIF (5) LAP SPONGE PREWASH 1 8" X 1 8" XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL (I) BLADE SURG I CAL#1 5 CARBON STEEL (I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F (2) PVP PAINT 8" STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53" X 77" LIF (I)S UTURE BAG FLORAL (I) SY RINGE I Occ SLI P TI P ST. LIF (I) NEEDLE HYPODERM IC 22G X I \12 ST. (I) SOLUTION SURG I CAL DURAPREP 26M L LIF (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP (2) GOWN FAB REINFORCED X-LARGE SONTARA (I) DRAPE TLAPAROT. 1 02" X 78" X 1 21 " STD SMS 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
Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; DeRoyal C-SECTION TRAY, REF 89-5256.06 Lot Number: 26185242; DeRoyal C V MINOR TRAY, REF 89-5277.02 Lot Number: 25793211; DeRoyal COMBINED EXTREMITY PACK, REF 89-6773.02 Lot Numbers: 25744022, 26010670, 26194641; DeRoyal DISKECTOMY TRAY, REF 89-6196.03 Lot Number: 26097373; DeRoyal MAJOR DRAPE PACK, REF 89-7255.01 Lot Number: 26011736; DeRoyal EXTREMITY PACK PGYBK, REF 89-5275.05 Lot Number: 26063270; DeRoyal SCOPE SHOULDER TRAY, REF 89-5653.03 Lot Number: 26227422; DeRoyal KNEE SCOPE PACK, REF 89-5654.03 Lot Number: 26020510; DeRoyal BILATERAL DRAPE, REF 89-5379.02 Lot Number: 26042735, 26282421; DeRoyal LAPAROSCOPIC CHOLE PACK, REF 89-5259.05 Lot Number: 25817201; DeRoyal MAJOR HIP PACK, REF 89-4718.04 Lot Number: 25840313; DeRoyal SPINE PACK, REF 89-4150.06 Lot Number: 25933077; DeRoyal ARTHROSCOPY TRAY, REF 89-5317.02 Lot Number: 26078463; DeRoyal LARGE VASCULAR TRAY, Lot Number: 26078447; DeRoyal SMALL VASCULAR TRAY, REF 89-3694.13 Lot Number: 261449399; DeRoyal ASC VASCULAR PACK PGYBK, REF 89-6284.05 Lot Number: 25698986; DeRoyal ASC BREAST PACK, REF 89-6285.06, Lot Number: 26078578; DeRoyal ASC FOOT/ANKLE PACK, REF 89-6014.07 Lot Numbers: 26096856, 26147916; DeRoyal ACUTE BURN EXCISION TRAY, REF 89-3330.05 Lot Number: 26078367; DeRoyal RECONSTRUCTION TRAY, REF 89-3331.04 Lot Numbers: 25817383, 26019720; DeRoyal FOOT PACK, REF 89-6467.05 Lot Number: 25880438; DeRoyal TRAUMA PACK, REF 89-6776.04 Lot Number: 26010688; DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5257.08 Lot Numbers: 26125434, 26149102; DeRoyal CHILDRENs ORTHOPEDIC TRAY, REF 89-3479.08 Lot Numbers: 25873676, 25905092 DeRoyal KNEE SCOPE, REF 89-2910.09 Lot Number: 25695611; DeRoyal SPINE PACK PGYBK, REF 89-6720.01 Lot Number: 26022048; DeRoyal OPEN SHOULDER PROCEDURE PACK, REF 89-6629.01 Lot Number: 25839187; DeRoyal ORTHO TOTAL BASIC TRAY, REF 89-2650.15 Lot Numbers: 25893423, 26010207, 26077111; DeRoyal ORTHO TOTAL HIP/KNEE TRAY, REF 89-2644.17 A & B Lot Number: 25894012; DeRoyal MINOR/PLASTIC PACK, REF 89-6994.02 Lot Number: 25853544; DeRoyal OPEN HEART PACK, REF 89-6996.02 Lot Number: 25853608; DeRoyal GEN SURG UNIV PACK, REF 89-6991.02 Lot Number: 25696032; DeRoyal PERI VASCULAR PACK, REF 89-6998.03 Lot Number: 25853587; DeRoyal VASCULAR PACK, REF 50-4157.29 Lot Number: 25732507; DeRoyal OPEN HEART B, REF 50-13010.19 Lot Number: 26009978; DeRoyal GENERAL ORTHO PACK, REF 89-6883.02 Lot Number: 25695911; DeRoyal HIP COUNTABLES TRAY, REF 89-5382.03 Lot Number: 26020464; DeRoyal BASIC ORTHO TRAY, REF 89-3389.11 Lot Number: 26010291; DeRoyal TOTAL KNEE PACK, REF 89-7114.02 Lot Number: 26012780; DeRoyal ACF TRAY, REF 89-7660.01 Lot Number: 26022656; DeRoyal HAND PACK, REF 89-7549.02 Lot Numbers: 26042330, 26147713; DeRoyal ORTHO PACK, REF 89-7546.02 Lot Numbers: 26025242, 26025717; DeRoyal THORACOTOMY PACK, REF 89-7536.02 Lot Number: 26022161; DeRoyal LAPAROSCOPIC GYN PACK, REF 89-7500.02 Lot Number: 26096063; DeRoyal ELG/AAA PACK, REF 89-7495.02 Lot Number: 26256371; DeRoyal PEDI OPEN HEART PACK, REF 89-7486.02 Lot Number: 26100624; DeRoyal TOTAL KNEE PACK, REF 89-7484.01 Lot Number: 25875196; DeRoyal TOTAL KNEE PACK, REF 89-7466.01 Lot Number: 26013301; DeRoyal CUSTOM TOTAL HIP PACK, REF 89-7465.03 Lot Number: 26096039, 26166244; DeRoyal PERIPHERAL VASCULAR PACK, REF 89-7451.02 Lot Number: 26166252; DeRoyal NEURO PACK, REF 89-7396.01 Lot Number: 26061573; DeRoyal LABOR & DELIVER PACK, REF 89-7448.03 Lot Number: 26166236; DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-7446.02 Lot Number: 26096549; DeRoyal GENERAL MINOR PACK, REF 89-7365.01 Lot Numbers: 25838838, 26095765; DeRoyal CUSTOM GENERAL MAJOR PACK, REF 89-7357.01 Lot Nu
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code LRP·June 14, 2011