Device product
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 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-2164-2014
Product summary
- Event
- Event 68971
- Status
- Terminated
- Classification
- Class II
- Quantity
- 640 units
- Official record key
device-enforcement:Z-2164-2014
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. 2817530, 2852405, 2869455, 2883663
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.