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Recall Observatory FDA recall evidence

Device product

Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0253-2015

October 08, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 69448
Status
Terminated
Classification
Class I
Quantity
4710
Official record key
device-enforcement:Z-0253-2015

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: 113046906 140412564 140513040 140814664

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised sterility