Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration
FDA device recall Z-0813-2016 · posted 2016-02-16 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
- Action taken
- LivaNova sent an Urgent Safety Alert dated January 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advice on action to be taken: "Remove and discard the IFU included within the case packaging for the product. "A copy of the correct IFU (Part Number 435085202, Revision B) is attached with this letter "Print copies of the IFU and place with the product. For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday BAM to 5PM MT) or e-mail USFieldSafetyActions@livanova.com. We sincerely apologize for this inconvenience and thank you in advance for your support
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 60
- Distribution
- US Distribution to CA., and Internationally to Canada.
- Date initiated
- 2016-01-25
- Date posted
- 2016-02-16
- Date terminated
- 2016-10-24
- Location
- Arvada, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AORTIC ARCH CANNULAS (K943934) | Sorin Group Italia S.R.L. | 1995-06-02 |