Recall Z-3229-2024
American Contract Systems, Inc. · initiated August 7, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Arthroscopy Pack, MSKA45A; Medical convenience kit
Codes / lots: UDI-DI: 00191072200938; Lot: 2405153; Exp: 05/15/2025
Reason for recall
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 confirm product sterilization assurance requirements were met.
FDA-determined cause: Under Investigation by firm
Action taken
Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Discard all affected kits and document on the enclosed Response Form."
Details
- Recall number
- Z-3229-2024
- Initiated
- August 7, 2024
- Posted by FDA
- September 24, 2024
- Product code
- OJH – Orthopedic Tray
- Quantity
- 48 units
- Distribution
- US Nationwide distribution in the states of MO, MN, MA, OH, NE.
- Recalling firm
- American Contract Systems, Inc., Kansas City, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3226-2024 Class II | PACEMAKER PACK, SLCV01J; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3227-2024 Class II | Endovascular AAA Pack, ESED52B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3228-2024 Class II | Endovascular AAA Pack, ESED52B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3230-2024 Class II | Open Shoulder, LWOS39L; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3231-2024 Class II | Day Surgery General Pack, FHGE18T; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3232-2024 Class II | Shoulder, SESH18I; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3233-2024 Class II | Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3234-2024 Class II | Paracentesis Thoracente, SLPT76H; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3235-2024 Class II | IR Procedure Pack, CEAT19W; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3236-2024 Class II | Neuro Vascular, ANKV91A; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3237-2024 Class II | Hand Pack, AKHD97C; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3238-2024 Class II | Vaginal Delivery, ASDV25B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3239-2024 Class II | Cath Lab Pack, CECL02P; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3240-2024 Class II | Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3241-2024 Class II | ENT, COEN27N; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3242-2024 Class II | Nasal Sinus Pack, MTSN26B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3243-2024 Class II | Cysto, FTCY03L; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3244-2024 Class II | Pacemaker, COPM11B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |