Device product
C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-0409-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 69448
- Status
- Terminated
- Classification
- Class I
- Quantity
- 600
- Official record key
device-enforcement:Z-0409-2015
Official wording
Reason: Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Code information: Lot numbers 140513148 140513469 140613849 140714552 140814963
Distribution pattern: US Distribution to Florida, New York and Puerto Rico..
Derived failure modes
-
Sterility assurance
compromised sterility