FDA-Device2022-06-08Class II

Joint Injection Tray Catalog Number: 8561R1

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
480 units
Manufactured in
75 Arkay Dr, N/A, Hauppauge, NY, United States
Products
Joint Injection Tray Catalog Number: 8561R1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2022

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