SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling SS 3.2MM Pellet Insertion Trays (Catalog Number B8110R1) distributed nationwide. The recall affects 300 units and involves swab/swabstick drug products manufactured by Professional Disposables International (PDI) that are included in Busse Convenience kits. The products are being recalled because of uncertainty regarding whether the test methods used during manufacturing were adequately validated. The affected lot numbers are 2030982, 2031072, 2130198, 2130352, 2130706, and 2130876, with UDI 00849233002227.
The source document does not specify a remedy or instructions for 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: 300 units Lot/code info: Lot Numbers: 2030982 2031072 2130198 2130352 2130706 2130876 UDI: 00849233002227
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.