Device product
CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.
Z-2281-2013
Product summary
- Event
- Event 66152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,850 units
- Official record key
device-enforcement:Z-2281-2013
Official wording
Reason: CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.
Code information: Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.
Distribution pattern: IL
Derived failure modes
-
Unknown
CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.