PlainRecalls
FDA Devices Moderate Class II Terminated

Pellet Insertion Tray Catalog Number: B1654

Reported: June 8, 2022 Initiated: February 22, 2022 #Z-1196-2022

Product Description

Pellet Insertion Tray Catalog Number: B1654

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

Details

Units Affected
50 units
Distribution
Nationwide
Location
Hauppauge, NY

Frequently Asked Questions

What product was recalled?
Pellet Insertion Tray Catalog Number: B1654. Recalled by Busse Hospital Disposables, Inc.. Units affected: 50 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1196-2022.