Epidural Tray Catalog 1577
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Epidural Tray Catalog 1577 (Busse Convenience kits) distributed nationwide. The kits contain swab or swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall due to uncertainty about whether the test methods used to manufacture these products were adequately validated. The recall affects 80 units with lot numbers 2130426, 2130801, 2131032, 2131138, and 2131290, and UDI 00849233006546.
The source document does not specify what action affected consumers should take in response to this recall.
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: 80 units Lot/code info: Lot Numbers: 2130426 2130801 2131032 2131138 2131290 UDI: 00849233006546
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.