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Recall Observatory FDA recall evidence

Device product

LAPAROTOMY SURGICAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Z-2657-2015

July 10, 2015

Class II

Product summary

Firm
Customed, Inc
Event
Event 71721
Status
Terminated
Classification
Class II
Quantity
1866
Official record key
device-enforcement:Z-2657-2015

Official wording

Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Code information: Code:900281A Lots: 140814951 exp. 2/28/16 140714543 exp. 2/28/16 141015713 exp. 10/31/15 150116503 exp. 12/31/15 150116513 exp. 12/31/15 150116514 exp. 12/31/15 150116515 exp. 12/31/15 141216437 exp. 12/31/15 150116939 exp. 2/28/16 150116940 exp. 2/28/16 150116938 exp. 2/28/16 150116941 exp. 2/28/16 150116937 exp. 2/28/16 150317732 exp. 3/31/16 150317731 exp. 3/3/16 150317734 exp. 3/31/16 150317733 exp. 3/31/16 150317954 exp. 4/30/16 150317957 exp. 4/30/16 150317958 exp. 4/30/16 150317959 exp. 4/30/16 150317960 exp. 4/30/16 150317961 exp. 4/30/16 150418383 exp. 4/30/16 150418384 exp. 4/30/16 150418385 exp. 4/30/16 150518790 exp. 5/31/16 150519028 exp. 5/31/16 150519029 exp. 5/31/16

Distribution pattern: Distributed Only in Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    inadequate validation/qualification of sterilization processes
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    inadequate validation/qualification of sterilization