104 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF (1) UMBILICAL CORD CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) UTILITY BOWL 16oz LIF (2) TRAY ORGANIZER FULL DEEP (3) ABSORBENT TIP APPLICATOR (2) GLOVE EXAM MEDIUM (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP (10) GAUZE SPONGE 4" X 4" 12PLY (2) PAD OBSTETRICAL X-LARGE ST. LIF (1) EAR ULCER SYRINGE 2oz UF (1) BABY BEANNIES (2) DRAPE SHEET 41 " X 58" SMS (1) SCISSORS UMBILICAL (1) TABLE COVER REINFORCED 44" X 78" L/F (2) WRAPPER 24" X 24" LI 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
PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE FLORAL (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) GOWN IMPERV. EXTRA REINF LGE AAMI LEVEL Ill T/WRAP (1) CATHETER 16" 18FR MALE PVC (2) LEGGINS W/7'' CUFF 30" X 44" 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
08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP (1) BABY BLANKET 30" X 30" POLY ABSOR.IMP. (1) PACKING VAGINAL XRD 4" X 36" 8PLY (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE ABDOMINAL WITAPE 40" X 54" (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" (2) PAD OBSTETRICAL XL (1) EAR ULCER SYRINGE 2oz. 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 OKV·May 20, 2014
OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014
OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014
Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 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
Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·January 7, 2016
Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
FDA Recall
Terminated
·Avid Medical, Inc.·Product code OKV·March 15, 2017
Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF (1) SYRINGE EAR/ULCER 2oz. LIF (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF (2) LEGGINS W/7'' CUFF 30X42 L/F (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) OB PAD WRAP OVERNIGHT (1) TABLE COVER REINFORCED 50X90 LIF (1) DRAPE UNDERBUTTOCK W/POUCH 44X35" (1) CLAMP UMBILICAL CORD LIF (1) BOWL PLASTIC 80oz. LIF (1) LID FOR BOWL 80oz. CLEAR LIF (1) BEANNIES BABY (5) LAP SPONGE PREWASH 18X18XRD (1) MAYO TRAY SMALL (1) DRAPE SHEET 41X58 SMS LIF (1) UNDERPAD 36X36 BEIGE (1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON (10) GAUZE SPONGE 4X4 16PLY 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 OKV·May 20, 2014
O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY ABSORBENT IMPERVIOUS (I) CORD UMBILICAL CLAMP (4) TOWELS ABSORBENT 15" x 20" LIF ( I) UTILITY BOWL 16oz. (2) TRAY ORGANIZER FULL DEEP (3) T IP ABSORBENT APPLICATOR (2) GLOVES EXAM MEDIUM (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (10) GAUZE SPONGE 4" X 4" 12PLY (2) PAD OBSTETRJCAL X-LARGE ST. (I) EAR ULCER SYRINGE 2oz. LIF (I) BABY BEANNIES (2) SHEET DRAPE 4 1" x 58" SMS LIF (I) SCISSORS UMBILICAL (I) TABLE COVER REINFORCED 50" x 90" LIF (2) WRAPPER 24" X 24" 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 OKV·May 20, 2014
Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014
LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·July 10, 2015
O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·July 10, 2015
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
FDA Recall
Terminated
·Avid Medical, Inc.·Product code OKV·February 18, 2020
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT TOWELS 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 50" X 90" UF (1) ABDOMINAL DRAPE WITH TAPE UF (1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) PAD OBSTETRICAL XL LIF (2) SPECIMEN CONTAINER 4oz. W/LID & LABEL (1 ) SYRINGE 1 Occ PREFILLED W/GEL (1 ) DRAPE SHEET 41 " X 69" MEDIUM UF (1 ) CATHETER 14FR. ROB. NELAT (1) NON-ADHESIVE TELFA DRESSING (2) GOWN IMP. REINFORCED LGE SMS 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
C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BLANKET BABY 30" X 30" POLYABS IMPERVIOUS LIF (1) SYRINGE EAR/ULCER 2oz LIF (2) PAD OBSTETRICAL X-LARGE (1) BOWL WITH/LID PLASTICS 80oz LIF (1) CLAMP UMBILICAL CORD LIF (1) BAG SUTURE FLORAL LIF (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF (1) COVER TABLE REINFORCED 50" X 90" 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 OKV·May 20, 2014
Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr. SURGICAL GLOVE # 7Y2 (1) UNDER BUTTOCK DRAPE WITH POUCH (1) BEANNIES BABY LIF (1) FEEDING TUBE 8 Fr. 15" LONG LIF (1) ABDOMINAL DRAPE WITH TAPE L/F (1) DRAPE SHEET 41 " X 58" SMS (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV (1) VAGINAL SPONGE XRD (1) UMBILICAL CORD CLAMP LIF (2) CLOTH HUCK TOWELS BLUE (1 0) GAUZE SPONGE 4" X 4"16 PLY XRD LIF (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2 (1) MUCUSTRAP 20cc 1 OFr. (1) BOWL PLASTIC 80oz WITH LID (1) WRAPPER 24" X 24" 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, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014
O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014