1,565 results found for sterilization
Page 8 of 63
American Contract Systems Inc
Class IIOngoing
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
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-1336-2025March 26, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-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-1345-2025March 26, 2025Tiffin, OH
American Contract Systems Inc
Class IIOngoing
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
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-1334-2025March 26, 2025Tiffin, OH
HF Acquisition Co LLC
Class IIOngoing
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Reason: Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results t...
Z-1141-2025February 19, 2025Mukilteo, WA
Hologic, Inc
Class IICompleted
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Reason: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Z-0669-2025December 18, 2024Marlborough, MA
American Contract Systems, Inc.
Class IIOngoing
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3242-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
IR Procedure Pack, CEAT19W; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3235-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Vaginal Delivery, ASDV25B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3238-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Endovascular AAA Pack, ESED52B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3227-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3233-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Endovascular AAA Pack, ESED52B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3228-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3234-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Hand Pack, AKHD97C; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3237-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
ENT, COEN27N; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3241-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Open Shoulder, LWOS39L; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3230-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Shoulder, SESH18I; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3232-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Arthroscopy Pack, MSKA45A; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3229-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3240-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Cysto, FTCY03L; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3243-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Cath Lab Pack, CECL02P; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3239-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Pacemaker, COPM11B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3244-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Day Surgery General Pack, FHGE18T; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3231-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
PACEMAKER PACK, SLCV01J; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3226-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Neuro Vascular, ANKV91A; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3236-2024October 2, 2024Kansas City, MO
MICROspecialties, Inc.
Class IIOngoing
Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
Reason: Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.