Device product
Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-0376-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 69448
- Status
- Terminated
- Classification
- Class I
- Quantity
- 242
- Official record key
device-enforcement:Z-0376-2015
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 140513144 140513338 140613746 140613832 140814544
Distribution pattern: US Distribution to Florida, New York and Puerto Rico..
Derived failure modes
-
Sterility assurance
compromised sterility