Recall Z-1070-2019— ICU Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by ICU Medical, Inc., initiated 2018-11-27, terminated 2022-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO. Reason: Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-27
- Terminated
- 2022-02-01
- Firm location
- San Clemente, CA, United States
Product description
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
Reason for recall
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
Data sourced from openFDA. This site is unofficial and independent of the FDA.