74 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
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
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code LOB·June 3, 2020
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Metal Catalog Number : 45-546
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/6.6/SL/T/A Catalog Number: PRTA66A
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Plastic Catalog Number: 45-559
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Banana Peel Sheaths BP/11/15 Catalog Number: 20-607
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/2.6/63 Catalog Number : 45-220
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Metal Catalog Number: 45-558
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Implantable Chest Ports With PASV Valve Technology -Single Lumen - PASV Port/6.6/SL/T/PA Catalog Number: PRTA66P
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
FDA Recall
Terminated
·Cook Inc.·Product code KOB·January 4, 2019
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog Number : 45-356
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/A Catalog Number: PRTB10A
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Banana Peel Sheaths BP/12/15 Catalog Number: 20-608
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Plastic Catalog Number : 45-547
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Vaxcel Chronic Dialysis Catheter - Catheter/PU/14/23/Plastic Catalog Number : 45-520
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/S/8/1.4/2.6/63 Catalog Number : 45-368
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/19/Metal Catalog Number : 45-542
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/TL/10/IK Catalog Number: CVC1003IK
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005
Banana Peel Sheaths - 11/30 Catalog Number: 260201
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOB·July 22, 2005