Recall record at a glance
| Official record | Z-1700-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Edwards Lifesciences, LLC |
| Report date | Jun 10, 2015 |
| Recall initiation date | May 5, 2015 |
| Quantity | 978 |
| Location | Irvine, CA, United States |
Official product description
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
Why the product was recalled
The product failed to meet the internal established statistical test requirement for heparin activity.
Distribution information
Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
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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