Single Shot Epidural Tray Catalog Number: 6183R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Single Shot Epidural Trays (Catalog Number 6183R1) nationwide. The recall affects 425 units because these convenience kits contain swab and swabstick products manufactured by Professional Disposables International (PDI) that are subject to a drug recall. The issue stems from uncertainty about whether the test methods used to manufacture these swab products were properly validated.
The affected lot numbers are 2030967, 2031172, 2031272, 2130029, 2130151, 2130298, 2130357, 2130459, 2130527, 2130593, 2130716, 2130863, 2130975, 2131088, 2131120, 2131224, and 2131248 (UDI: 00849233007857). The recall source does not specify a remedy or what affected consumers should do.
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: 425 units Lot/code info: Lot Numbers: 2030967 2031172 2031272 2130029 2130151 2130298 2130357 2130459 2130527 2130593 2130716 2130863 2130975 2131088 2131120 2131224 2131248 UDI: 00849233007857
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.