Single Shot Epidural Tray Catalog Number: 8417
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables is recalling Single Shot Epidural Trays (Catalog Number 8417) distributed nationwide. The trays contain swab or swabstick products manufactured by Professional Disposables International (PDI) that are subject to recall due to uncertainty about whether the test methods used to manufacture these drug products were adequately validated. A total of 400 units are affected, with the following lot numbers involved: 2130077, 2130313, 2130630, 2130945, and 2131091. The product's UDI is 00849233016804.
The recall notice does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Nationwide Quantity: 400 units Lot/code info: Lot Numbers: 2130077 2130313 2130630 2130945 2131091 UDI: 00849233016804
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.