Device product
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Z-0221-2016
Product summary
- Event
- Event 72384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,000 units
- Official record key
device-enforcement:Z-0221-2016
Official wording
Reason: CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Code information: Lot No. 15015769, 15035412, 15045950.
Distribution pattern: Distributed US (nationwide) and in Canada.
Derived failure modes
-
Unknown
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.