Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables is recalling its Male SS 4.5MM Pellet Insertion Tray (Catalog Number B9176R1) nationwide. The recall affects 360 units across four lot numbers (2031047, 2031162, 2130578, and 2130723). The tray contains swab or swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall due to concerns about whether the test methods used during manufacturing were adequately validated.
The source document does not specify what consumers or healthcare facilities 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: 360 units Lot/code info: Lot Numbers: 2031047 2031162 2130578 2130723 UDI: 00849233011151
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.