Device product

Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-1487-2016

January 07, 2016

Class II

Product summary

Firm: Customed, Inc
Event: Event 72992
Status: Terminated
Classification: Class II
Quantity: 800
Official record key: device-enforcement:Z-1487-2016

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: LOTS: SL15177 (150619315) 30-JUN-16 SL15268 (150719854) 30-SEP-16 SL15271 (150719854) 30-SEP-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