Skip to content
Recall Observatory FDA recall evidence

Device product

CYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Z-2660-2015

July 10, 2015

Class II

Product summary

Firm
Customed, Inc
Event
Event 71721
Status
Terminated
Classification
Class II
Quantity
176
Official record key
device-enforcement:Z-2660-2015

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:9002899 Lots: 141015716 exp. 2/28/16 141216326 exp. 12/31/15 150116504 exp. 12/31/15 150116944 exp. 2/28/16 150418447 exp. 4/30/16 150418491 exp. 4/30/16 150518912 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