Recalls / —
—#148907
Product
Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
- FDA product code
- DRS — Transducer, Blood-Pressure, Extravascular
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K061573
- Affected lot / code info
- lot number 3264103
Why it was recalled
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Root cause (FDA determination)
Process control
Action the firm took
An Urgent Medical Device Recall Notification letter dated 8/10/16 was sent to all their customers who purchased the Transpac IV with SafeSet reservoir kit and without SafeSet Reservoir, and with Transpac IV with marvelous valve without SafeSet reservoir. The letter informs the customers that ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The recall letter list the affected products and lot numbers. Customers are informed of the actions to be taken. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to recall@icumed.com.
Recalling firm
- Firm
- ICU Medical, Inc.
- Address
- 951 Calle, Amanecer San Clemente, California 92673-6212
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2016-08-10
- Posted by FDA
- 2016-09-15
- Terminated
- 2017-07-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #148907. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.