Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Female SS 3.5MM Pellet Insertion Trays (Catalog Number B9175R1) distributed nationwide. The trays contain swab or swabstick drug products manufactured by Professional Disposables International (PDI). The recall was issued because there is uncertainty about whether the test methods used to manufacture these drug products were properly validated. A total of 1,040 units are affected, with lot numbers including 2030875, 2030980, 2031048, 2031096, 2130563, and 2130722.
The source document does not specify what affected consumers should do 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: 1040 units Lot/code info: Lot Numbers: Lot 2030875 2030980 2031048 2031048 2031096 2031048 2031096 2130563 2130722 UDI: 00849233011182
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.