Device product
Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-0243-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 69448
- Status
- Terminated
- Classification
- Class I
- Quantity
- 134160
- Official record key
device-enforcement:Z-0243-2015
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: 111113095 111123232 112010156 112020472 112030761 112041313 112062452 112072959 112082969 112083427 112104362 112114536 112124889 113026115 113036350 113036799 113047312 113068166 113109823 131110258 131210686 140312144 140412667 140513046 140613603 140714263 140814789 140915159
Distribution pattern: US Distribution to Florida, New York and Puerto Rico..
Derived failure modes
-
Sterility assurance
compromised sterility