Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E
FDA device recall Z-0217-2015 · posted 2014-11-14 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.
- Action taken
- Edward Lifesciences sent an Urgent Medical Device Safety Notice date October 8, 2014, via Fed-Ex to all affected customers. On 3/4/15, letters were sent to surgeons. As part of the customer instructions in the safely notice, customers were requested to forward copies of the safely alert to any organization where the potentially affected devices have been transferred. No product is being returned. The distribution of the device has not been stopped as a result of this field correction. No additional production lots will be released for distribution until the IFU has been revised. Customers with questions were instructed to call (800) 424-3278. For questions regarding this recall call 801-553-7531.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 157,305
- Distribution
- Worldwide Distribution - USA including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachuset
- Date initiated
- 2014-10-08
- Date posted
- 2014-11-14
- Date terminated
- 2016-12-15
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA (K113411) | Edwards Lifesciences, LLC | 2012-06-11 |