1,565 results found for sterilization
Page 6 of 63
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CA...
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2464-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2471-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; ...
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2466-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, ...
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2472-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2469-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item...
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2465-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2470-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;...
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2467-2025September 3, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further...
Z-2468-2025September 3, 2025Tiffin, OH
Olympus Corporation of the Americas
Class IIOngoing
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2146-2025July 30, 2025Center Valley, PA
Bridge to Life Ltd
Class IIOngoing
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Reason: The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine...
Z-2157-2025July 30, 2025Northbrook, IL
Olympus Corporation of the Americas
Class IIOngoing
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2145-2025July 30, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2143-2025July 30, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen w...
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2139-2025July 30, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2144-2025July 30, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2141-2025July 30, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some...
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2140-2025July 30, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Reason: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Z-2026-2025July 2, 2025Cedar Grove, NJ
Jewel Precision Sheet Metal & Machining Co, Inc.
Class IIOngoing
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Reason: The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the ch...
Z-2033-2025July 2, 2025Cedar Grove, NJ
American Contract Systems Inc
Class IIOngoing
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Z-1362-2025March 26, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Z-1339-2025March 26, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Z-1342-2025March 26, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
BORN ON ARRIVAL KIT , Model No LLBN11B
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Z-1341-2025March 26, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
AV FISTULA , Model No UTAV77T
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.