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Recall Observatory FDA recall evidence

Device product

Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Z-0184-2020

June 19, 2019

Class II

Product summary

Firm
Andover Healthcare Inc.
Event
Event 83239
Status
Terminated
Classification
Class II
Quantity
1050 Cases
Official record key
device-enforcement:Z-0184-2020

Official wording

Reason: Incomplete packaging seal of sterile product

Code information: Manufacturer's product or Catalog # 7400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0X0D, CI18K8, CI1DXN

Distribution pattern: US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Incomplete packaging