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Recall Observatory FDA recall evidence

Device product

Kit: Central Line Dres Change 20/Cs

Z-0147-2022

September 08, 2021

Class II

Product summary

Firm
Medical Action Industries, Inc. 306
Event
Event 88687
Status
Terminated
Classification
Class II
Quantity
42 cases
Official record key
device-enforcement:Z-0147-2022

Official wording

Reason: The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

Code information: Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024 UDI: 20809160170523

Distribution pattern: Distribution to a single US distributor in Michigan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.