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Recall Observatory FDA recall evidence

Device product

Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0247-2015

October 08, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 69448
Status
Terminated
Classification
Class I
Quantity
13680
Official record key
device-enforcement:Z-0247-2015

Official wording

Reason: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information: Lot numbers: 112020506 112030882 112062454 112093946 112114888 113047160 113068174 113109854 131210826 140211849 140412693 140613605 140915161

Distribution pattern: US Distribution to Florida, New York and Puerto Rico..

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised sterility