Reported Nov 23, 2016 · Terminated
ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 The Transpac Disposable Straight…
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?
- ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 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
- 3264124
- Amount recalled
- 190 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new ICU Medical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.