Reported Nov 23, 2016 · Terminated
TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No.…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 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.
- Lot codes and dates
- 3226274 3264108 3265439 3269745 3280964
- Amount recalled
- 1740 units
This recall covers 162 products
The agency filed one notice per product. You are reading one of them; the other 161 are below.
149 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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