Recall Z-2179-2020
American Contract Systems · initiated April 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sterile Custom Packs to be used in surgical procedures.
Codes / lots: ACS Tray Numbers: AVLC19G; Lot # 642191, Exp. Date 12/24/2020 (64 kits)
Reason for recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
FDA-determined cause: Process control
Action taken
Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
Details
- Recall number
- Z-2179-2020
- Initiated
- April 13, 2020
- Terminated
- November 25, 2020
- Product code
- PKE – Laparoscopic Cholecystectomy Kit
- Quantity
- 2,868 total kits
- Distribution
- US Nationwide distribution including in the state of Pennsylvania.
- Recalling firm
- American Contract Systems, Zelienople, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2166-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2167-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2168-2020 Class II | Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2169-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2170-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2171-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2172-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2173-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2174-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2175-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2176-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2177-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2178-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |