3.2MM Pellet Insertion Tray Catalog Number: B9743
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables is recalling its 3.2MM Pellet Insertion Tray (Catalog Number B9743), which is a convenience kit containing swab and 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. A total of 150 units were distributed nationwide, affecting products with lot numbers 2031128, 2130202, and 2131304.
The affected products can be identified using the UDI (Unique Device Identifier) 00849233011649. According to the recall record, no specific remedy or consumer action is specified.
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: 150 units Lot/code info: Lot Numbers: 2031128 2130202 2131304 UDI: 00849233011649
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.