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Recall Observatory FDA recall evidence

Device product

MAJOR LAP PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Z-2673-2015

July 10, 2015

Class II

Product summary

Firm
Customed, Inc
Event
Event 71721
Status
Terminated
Classification
Class II
Quantity
2736
Official record key
device-enforcement:Z-2673-2015

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:900404 Lots: 140915488 exp. 10/31/15 141216330 exp. 12/31/15 141216438 exp. 12/31/15 141216438 exp. 12/31/15 150116533 exp. 2/28/16 150116807 exp. 2/28/16 150116808 exp. 2/28/16 150116809 exp. 2/28/16 150116810 exp. 2/28/16 150116811 exp. 2/28/16 150217401 exp. 2/28/16 150217402 exp. 2/28/16 150217404 exp. 2/28/16 150217405 exp. 2/28/16 150217403 exp. 2/28/16 150217406 exp. 2/28/16 150217407 exp. 2/28/16 150217408 exp. 2/28/16 150217409 exp. 2/28/16 150317803 exp. 3/31/16 150317805 exp. 3/31/16 150317808 exp. 3/31/16 150317807 exp. 3/31/16 150317809 exp. 3/31/16 150317806 exp. 3/31/16 150418397 exp. 4/30/16 150418398 exp. 4/30/16 150418399 exp. 4/30/16 150418400 exp. 4/30/16 150418499 exp. 4/30/16 150418500 exp. 4/30/16 150418501 exp. 4/30/16 150418498 exp. 4/30/16 150519002 exp. 5/31/16 150519004 exp. 6/30/16 150519003 exp. 6/30/16 150519005 exp. 6/30/16 150619464 exp. 6/30/16 150619463 exp. 6/30/16 150619385 exp. 6/30/16 150619466 exp. 6/30/16

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