—#143595

Product

Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K943934
Affected lot / code info: lot - 1529300018

Why it was recalled

Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.

Root cause (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: US Distribution to CA., and Internationally to Canada.

Timeline

Recall initiated: 2016-01-25
Posted by FDA: 2016-02-16
Terminated: 2016-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143595. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.