1,565 results found for sterilization
Page 9 of 63
Synergetics Inc
Class IOngoing
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Reason: Sterilization certificates could not be validated by the supplier
Z-2254-2024July 17, 2024O Fallon, MO
MICROspecialties, Inc.
Class IIOngoing
Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
Reason: Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Z-2336-2024July 17, 2024Middletown, CT
Synergetics Inc
Class IOngoing
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Reason: Sterilization certificates could not be validated by the supplier
Z-2251-2024July 17, 2024O Fallon, MO
Synergetics Inc
Class IOngoing
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Reason: Sterilization certificates could not be validated by the supplier
Z-2253-2024July 17, 2024O Fallon, MO
Synergetics Inc
Class IOngoing
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Reason: Sterilization certificates could not be validated by the supplier
Z-2252-2024July 17, 2024O Fallon, MO
MICROspecialties, Inc.
Class IIOngoing
Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Reason: Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Z-2335-2024July 17, 2024Middletown, CT
MICROspecialties, Inc.
Class IIOngoing
Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
Reason: Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Z-2334-2024July 17, 2024Middletown, CT
Howmedica Osteonics Corp.
Class IIOngoing
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Reason: The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gr...
Z-2152-2024June 26, 2024Mahwah, NJ
Howmedica Osteonics Corp.
Class IIOngoing
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Reason: The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gra...
Z-2153-2024June 26, 2024Mahwah, NJ
Cardinal Health 200, LLC
Class IIOngoing
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Reason: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril...
Z-1739-2024May 8, 2024Waukegan, IL
Cardinal Health 200, LLC
Class IIOngoing
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Reason: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril...
Reason: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril...
Reason: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril...
Reason: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril...
Z-1735-2024May 8, 2024Waukegan, IL
Covidien, LP
Class IIOngoing
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
Reason: One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which ...
Z-1697-2024May 8, 2024North Haven, CT
Covidien
Class IIOngoing
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Reason: Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't...
Z-1330-2024March 27, 2024Lafayette, CO
Paragon 28, Inc.
Class IIOngoing
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Reason: Medical devices distributed, prior to sterilization
Reason: Medical devices distributed, prior to sterilization
Z-1256-2024March 13, 2024Englewood, CO
Paragon 28, Inc.
Class IIOngoing
Phantom TTC Nail, 10.0 X 200mm, Right
Reason: Medical devices distributed, prior to sterilization
Z-1254-2024March 13, 2024Englewood, CO
Globus Medical, Inc.
Class IIOngoing
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Reason: Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an incre...
Z-1007-2024February 14, 2024Audubon, PA
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) L...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0822-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0829-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatri...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0819-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c)...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0825-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit numbe...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...