SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling SS 4.5MM Pellet Insertion Trays with Medium Gloves (Catalog Number B1365R1) nationwide. The recall affects 60 units and involves swab and swabstick drug products manufactured by Professional Disposables International (PDI) that are included in these convenience kits. The recall was issued because there is uncertainty about whether the test methods used to manufacture these drug products were adequately validated.
The affected products have lot numbers 2110128 and 2110279, and carry the UDI 00849233004412. The source document does not specify what actions consumers or healthcare facilities 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: 60 units Lot/code info: Lot Numbers: 2110128 2110279 UDI: 00849233004412
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.