3.2MM Pellet Insertion Tray Catalog Number: B1144
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables is recalling 120 units of its 3.2MM Pellet Insertion Tray (Catalog Number B1144) nationwide. The tray contains swab or swabstick products manufactured by Professional Disposables International (PDI) that are subject to a drug recall. The recall was issued due to uncertainty about whether the test methods used to manufacture these drug products were properly validated. The affected lot numbers are 2010270, 2110081, 2110173, and 2110220.
The recall record does not specify a remedy or corrective action that consumers should take.
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: 120 units Lot/code info: Lot Numbers: 2010270 2110081 2110173 2110220 UDI: 00849233003835
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.