Skip to content
Recall Observatory FDA recall evidence

Device product

LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Z-2610-2015

July 10, 2015

Class II

Product summary

Firm
Customed, Inc
Event
Event 71721
Status
Terminated
Classification
Class II
Quantity
2142
Official record key
device-enforcement:Z-2610-2015

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:900176 Lots: 141216310 exp. 12/31/15 150116977 exp. 1/31/16 150116977 exp. 1/31/16 150116775 exp. 1/31/16 150116772 exp. 1/31/16 150116774 exp. 1/31/16 150116773 exp. 1/31/16 150317694 exp. 3/31/16 150317695 exp. 3/31/16 150317696 exp. 3/31/16 150317697 exp. 3/31/16 150317698 exp. 3/31/16 150317693 exp. 3/31/16 150418316 exp. 4/30/16 150418317 exp. 4/30/16 150418578 exp. 4/30/16 150418579 exp. 4/30/16 150519009 exp. 5/31/16 150619364 exp. 6/30/16 150619365 exp. 6/30/16 150619366 exp. 6/30/16 150619367 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