FDAFDA · Food and drugs·Recall number Z-1194-2022
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Published June 8, 2022 · Recall initiated: February 22, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Busse Hospital Disposables, Inc.
- Distributor
- Nationwide
- Lot
- Lot Numbers: 2130338 2130562 UDI: 00849233005525
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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