FDA-Device2022-06-08Class II

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1

Busse Hospital Disposables, Inc.
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

Sold states
Nationwide
Affected count
360 units
Manufactured in
75 Arkay Dr, N/A, Hauppauge, NY, United States
Products
Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2022

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