Device product
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
Z-2159-2014
Product summary
- Event
- Event 68971
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,560
- Official record key
device-enforcement:Z-2159-2014
Official wording
Reason: ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Code information: Lot No. 2841944, 2841945, 2859326, 2865873, 2869445
Distribution pattern: Worldwide Distribution - USA including Oregon and Internationally to Australia.
Derived failure modes
-
Unknown
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.