Busse Hospital Disposables, Inc. Recall 90072
Description: Single Shot Epidural Tray Catalog Number: 6183R1
Busse Hospital Disposables, Inc. Recall 90072 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1169-2022 |
| Event ID | 90072 |
| Event Description | Single Shot Epidural Tray Catalog Number: 6183R1 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 425 units |
| Recall Reason | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products |
| Device Classification | 20220608 |
| Device Code Info | Lot Numbers: 2030967 2031172 2031272 2130029 2130151 2130298 2130357 2130459 2130527 2130593 2130716 2130863 2130975 2131088 2131120 2131224 2131248 UDI: 00849233007857 |
| Center Classification Date | 20220528 |
| Recall Initiation Date | 20220222 |
| Recalling Firm | Busse Hospital Disposables, Inc. |
| Initial Notification | Letter |
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