American Contract Systems Inc Recall 94765
Description: ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
American Contract Systems Inc Recall 94765 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2281-2024 |
| Event ID | 94765 |
| Event Description | ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 272 units |
| Recall Reason | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| Device Classification | 20240717 |
| Device Code Info | UDI-DI: 00191072197825 LOT#"s: 665231 950241 |
| Center Classification Date | 20240705 |
| Recall Initiation Date | 20240515 |
| Recalling Firm | American Contract Systems Inc |
| Initial Notification | |
| Similar To |