FDA-Device2022-06-08Class II
Cervical Tray Catalog Number: 3765R2
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
40 units
Manufactured in
75 Arkay Dr, N/A, Hauppauge, NY, United States
Products
Cervical Tray Catalog Number: 3765R2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2022Don't want to check this manually?
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