—#150664

Product

TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 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: 3249839

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)

Device Design

Action the firm took

ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or potentially introduce small amounts of air into the line. Customers with questions were 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 2, or e-mail the following address: productreturns@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. Customers with questions were instructed to call 866-829-9025.

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-09-27
Posted by FDA: 2016-11-15
Terminated: 2017-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150664. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.