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Recall Observatory FDA recall evidence

Device product

Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955

Z-0344-2020

October 24, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 84165
Status
Terminated
Classification
Class II
Quantity
80 units
Official record key
device-enforcement:Z-0344-2020

Official wording

Reason: Sterile packaging incomplete seals may compromise sterility of the product

Code information: Lot/Batch Number: 2019052190 Exp Date: 5/31/2024

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterile packaging incomplete seals may compromise