Device product
Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-0242-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 69448
- Status
- Terminated
- Classification
- Class I
- Quantity
- 78600
- Official record key
device-enforcement:Z-0242-2015
Official wording
Reason: Customed products are being recalled because of 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: 111102823 111112980 111123314 111123440 112020308 112020361 112030826 112041369 112041434 112051646 112062317 112083160 112093741 112104363 112124894 113015487 113035832 113046996 113047144 113057604 113057810 113078456 113078674 113089014 113109706 131110154 131110288 131210677 140111108 140211531 140312046 140412578 140513065 140613570 140714155 140714430 140814942
Distribution pattern: US Distribution to Florida, New York and Puerto Rico..
Derived failure modes
-
Sterility assurance
compromised sterility