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Recall Observatory FDA recall evidence

Device product

"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351

Z-1180-2022

February 22, 2022

Class II

Product summary

Firm
Busse Hospital Disposables, Inc.
Event
Event 90072
Status
Terminated
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-1180-2022

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: 2110082 2110174 2110254 2110221 UDI: 00849233004733

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