Nerve Block Tray Catalog Number: 8415
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Nerve Block Trays (catalog number 8415) because these kits contain swab and swabstick products manufactured by Professional Disposables International (PDI). The recalled products are subject to a drug recall due to uncertainty about whether the test methods used to manufacture these products were properly validated. The recall affects 420 units distributed nationwide, with specific lot numbers identified as 2030832, 2031190, 2130252, 2130629, 2130742, 2131125, and 2131223. The product's UDI is 00849233016811.
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: 420 units Lot/code info: Lot Numbers: 2030832 2031190 2130252 2130629 2130742 2131125 2131223 UDI: 00849233016811
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.