Recall Z-2177-2020
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: WXCT12E; Lot # 998201, Exp. Date 001/02/2021 (70 kits) PTHS10C; Lot # 664191, Exp. Date 12/02/2020 (2 kits) AVHA64H; Lot # 663191, Exp. Date 12/06/2020 (30 kits) WXPO16G; Lot # 639191, Exp. Date 12/27/2020 (26 kits) and Lot # 689191, Exp. Date 11/07/2020 (6 kits) VSSA12G; Lot # 646191, Exp. Date 12/20/2020 (12 kits) AGBA20H: Lot 3 970191, Exp. Date 01/30/20 (2 kits) WXSA12H; Lot # 653191, Exp. Date 12/13/2020 (40 kits) WXKA26H; Lot # 981201, Exp. Date 01/19/2021 (18 kits) and Lot # 639191, Exp. Date 12/27/2020 (32 kits) WXHA64H; Lot # 682191, Exp. Date 11/14/2020 (18 kits); Lot # 636191, Exp. Date 12/30/2020 (121 kits) and Lot # 684191, Exp. Date 11/12/2020 (6 kits) AGKA26H; Lot # 992201, Exp. Date 01/08/2021 (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-2177-2020
- Initiated
- April 13, 2020
- Terminated
- November 25, 2020
- Product code
- OJH – Orthopedic Tray
- Quantity
- 2,8,68 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-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 |
| Z-2179-2020 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 |