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Recall Observatory FDA recall evidence

Device 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.

Z-0813-2016

January 25, 2016

Class II

Product summary

Firm
Sorin Group USA, Inc.
Event
Event 73224
Status
Terminated
Classification
Class II
Quantity
60
Official record key
device-enforcement:Z-0813-2016

Official wording

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

Code information: lot - 1529300018

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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