Recall record at a glance
| Official record | Z-2776-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Edward Lifesciences, LLC |
| Report date | Sep 23, 2015 |
| Recall initiation date | Jul 31, 2015 |
| Quantity | 13,077 (U.S.) and 12,306 (International) |
| Location | Irvine, CA, United States |
Official product description
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Why the product was recalled
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
Distribution information
Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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