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 Recall Z-0813-2016 · Posted 2016-02-16
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Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2016-01-25
Date Terminated2016-10-24
Product Quantity60
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.
Firm Action
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 [email protected].
We sincerely apologize for this inconvenience and thank you in advance for your support
Root Cause
Employee error
Distribution Pattern
US Distribution to CA., and Internationally to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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