Recalls / —
—#129172
Product
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 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.
- FDA product code
- DRS — Transducer, Blood-Pressure, Extravascular
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K061573
- Affected lot / code info
- Lot No. 2837897
Why it was recalled
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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.
Recalling firm
- Firm
- ICU Medical, Inc.
- Address
- 951 Calle, Amanecer San Clemente, California 92673-6212
Distribution
- Distribution pattern
- Worldwide Distribution - USA including Oregon and Internationally to Australia.
Timeline
- Recall initiated
- 2014-07-18
- Posted by FDA
- 2014-08-07
- Terminated
- 2014-09-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #129172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.