FDA-Device2022-06-08Class II
Single Shot Epidural Tray Catalog Number: 8417
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
400 units
Manufactured in
75 Arkay Dr, N/A, Hauppauge, NY, United States
Products
Single Shot Epidural Tray Catalog Number: 8417
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1159-2022Don't want to check this manually?
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