Skip to content
Recall Observatory FDA recall evidence

Device product

C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

Z-2712-2015

July 10, 2015

Class II

Product summary

Firm
Customed, Inc
Event
Event 71721
Status
Terminated
Classification
Class II
Quantity
874
Official record key
device-enforcement:Z-2712-2015

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: 900921A Lots: 141015499 exp. 3/31/16 141216451 exp. 1/31/16 141216364 exp. 12/31/15 150317861 exp. 3/31/16 150317860 exp. 3/31/16 150418472 exp. 4/30/16 150418473 exp. 4/30/16 150518583 exp. 5/31/16 150518584 exp. 5/31/16 150518913 exp. 5/31/16 150619191 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