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Recall Observatory FDA recall evidence

Device product

FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch

Z-0076-2018

September 28, 2017

Class II

Product summary

Firm
Sorin Group USA, Inc.
Event
Event 78331
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-0076-2018

Official wording

Reason: A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.

Code information: Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185

Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to France and Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.