Device product
Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-0254-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 69448
- Status
- Terminated
- Classification
- Class I
- Quantity
- 23300
- Official record key
device-enforcement:Z-0254-2015
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: 11123442 111112934 112041187 112051647 112051758 112062415 112072773 112083390 113026043 113026103 113026229 113057384 113068146 113078701 113109725 140613855 140814650
Distribution pattern: US Distribution to Florida, New York and Puerto Rico..
Derived failure modes
-
Sterility assurance
compromised sterility