Device product

Epidural Tray Catalog 1577

Z-1155-2022

February 22, 2022

Class II

Product summary

Firm: Busse Hospital Disposables, Inc.
Event: Event 90072
Status: Terminated
Classification: Class II
Quantity: 80 units
Official record key: device-enforcement:Z-1155-2022

Official wording

Reason: 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

Code information: Lot Numbers: 2130426 2130801 2131032 2131138 2131290 UDI: 00849233006546

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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