SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling SS 3.5MM Diamond Tip Trocar - Large Gloves (Catalog Number B1547) Convenience kits distributed nationwide. The kits contain one or more swab or swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall due to uncertainty about whether the test methods used to manufacture these drug products were adequately validated. A total of 60 units are affected, with Lot Numbers 2110054 and 2110116 (UDI: 00849233005365).
The source document does not specify a remedy or recommended action for consumers who may have this product.
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: 2110054 2110116 UDI: 00849233005365
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.