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Recall Observatory FDA recall evidence

Device product

Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12

Z-0953-2021

January 04, 2021

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 87088
Status
Terminated
Classification
Class II
Quantity
23,580 eaches
Official record key
device-enforcement:Z-0953-2021

Official wording

Reason: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

Code information: Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532

Distribution pattern: US Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging which could impact the seal and result in a sterility breach
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging which could impact the seal and result in a sterility breach