FDA-Device2022-06-08Class II

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

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
90 units
Manufactured in
75 Arkay Dr, N/A, Hauppauge, NY, United States
Products
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1184-2022

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