Skip to content
Recall Observatory FDA recall evidence

Device product

GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Z-2668-2015

July 10, 2015

Class II

Product summary

Firm
Customed, Inc
Event
Event 71721
Status
Terminated
Classification
Class II
Quantity
144
Official record key
device-enforcement:Z-2668-2015

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:9003190 Lots: 140915335 exp. 10/31/19 141015884 exp. 11/30/15 150116804 exp. 2/28/16 150317650 exp. 3/31/16 150418391 exp. 4/30/16 150518793 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