SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling SS 3.5MM Pellet Insertion Trays with Medium Gloves (Catalog Number B1354R1) distributed nationwide. The recall affects 90 units and involves Busse Convenience kits that 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 adequately validated.
The affected lots are 2110102, 2110090, and 2110268, which can be identified by the UDI 00849233004641. The source document does not specify what action 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: 90 units Lot/code info: Lot Numbers: 2110102 2110090 2110268 UDI: 00849233004641
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.