Device product
Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Z-0143-2014
Product summary
- Event
- Event 66249
- Status
- Terminated
- Classification
- Class II
- Quantity
- 628,992 units
- Official record key
device-enforcement:Z-0143-2014
Official wording
Reason: The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.
Code information: 10043, 10044
Distribution pattern: Worldwide Distribution - USA (nationwide) and the country of Canada.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter