Device product

Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-1465-2016

January 07, 2016

Class II

Product summary

Firm: Customed, Inc
Event: Event 72992
Status: Terminated
Classification: Class II
Quantity: 96
Official record key: device-enforcement:Z-1465-2016

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: SL15195-02 (150619269) 31-JUL-16 SL15251 (150820570) 31-AUG-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