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Recall Observatory FDA recall evidence

Device product

Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0249-2015

October 08, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 69448
Status
Terminated
Classification
Class I
Quantity
9200
Official record key
device-enforcement:Z-0249-2015

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: 111123296 112030746 112124854 112124886 113036382 113088890 131110313 140412880 140613780 140915163

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised sterility