Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems. Devic
FDA device recall Z-2777-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
- Action taken
- Edwards Lifesciences, LLC sent an Urgent Product Recall - Action Required letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusotmers were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards at: Edwards Lifesciences 12060 Lone Peak Pkwy Draper, UT 84020 Attention: Suzanne Carpenter, RGA # Customers were instructed to contact Customer Service to obtain a Returned Goods Authorization number and replacement product . Once customers verified their inventory, they were to complete the attached form and fax it to Edwards at (949) 250-3489. For any questions customers were instructed to call Edwards Customer Service at (800) 424-3278.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 97 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-06-15
- Date posted
- 2011-07-11
- Date terminated
- 2012-06-01
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER (K023880) | ETHICON, Inc. | 2002-12-11 |
| BAXTER HEMOSTASIS VALVE INTRODUCERS (K981909) | Baxter Edwards | 1998-11-24 |