Busse Hospital Disposables, Inc. Recall 90072
Description: Single Shot Epidural Tray Catalog Number: 8417
Busse Hospital Disposables, Inc. Recall 90072 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1159-2022 |
Event ID | 90072 |
Event Description | Single Shot Epidural Tray Catalog Number: 8417 |
Product Type | Devices |
Distribution | Nationwide |
Quantity | 400 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: 2130077 2130313 2130630 2130945 2131091 UDI: 00849233016804 |
Center Classification Date | 20220528 |
Recall Initiation Date | 20220222 |
Recalling Firm | Busse Hospital Disposables, Inc. |
Initial Notification | Letter |
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