Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifescien
FDA device recall Z-2196-2011 · posted 2011-05-13 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Llc
- Reason for recall
- Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.
- Action taken
- The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated January 21, 2011 it customers via Fed-Ex. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory for any of the lot numbers; return all unused product from their stock to Edwards; contact their Customer Service Organization at (800) 424-3278 to obtain a Returned Goods Authorization number and replacement product; complete and return the Aortic Perfusion Cannula Recall Response form via fax to: Edwards at (949) 250-3489, and return unused product to Edwards Lifesciences, 12050 Lone Peak Drive, Draper, UT 84020. If you have questions that have not been answered by this letter, call Edwards Customer Service at (800) 424-3278 from 8:00AM - 4:30PM Pacific Time.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 20
- Distribution
- Nationwide distribution: CA only.
- Date initiated
- 2011-01-21
- Date posted
- 2011-05-13
- Date terminated
- 2011-05-13
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE (K033463) | Edwards Lifesciences, LLC | 2004-07-28 |