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Recall Observatory FDA recall evidence

Device product

Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0378-2015

October 08, 2014

Class I

Product summary

Firm
Customed, Inc
Event
Event 69448
Status
Terminated
Classification
Class I
Quantity
1680
Official record key
device-enforcement:Z-0378-2015

Official wording

Reason: Significant 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 140513247 140613834 140714393 140814875

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised sterility