Universal Nerve Block Tray Catalog Number: 9779
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Universal Nerve Block Trays (catalog number 9779) distributed nationwide. These trays contain swab or swabstick drug products manufactured by Professional Disposables International (PDI). The recall affects 400 units across multiple lot numbers (2031030, 2130009, 2130328, and 2130645) due to uncertainty about whether the test methods used to manufacture the drug products were properly validated.
The source document does not specify what actions affected consumers should take regarding 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: 400 units Lot/code info: Lot Numbers: 2031030 2130009 2130328 2130645 UDI: 00849233012134
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.