CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
FlexFlow Venous Cannula recalled by Sorin Group USA
Sorin Group USA is recalling FlexFlow Venous Cannula, distributed nationwide in the US. The recall was initiated on 28 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0076-2018
- FDA event ID
- 78331
- Recalling firm
- Sorin Group USA, Arvada, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2017
- FDA classified
- 8 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 28 Sep 2017 | Recall initiated by company | |
| 8 Nov 2017 | Classified by FDA | +41 days |
| 15 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US (nationwide) Internationally to France and Spain
Questions about this recall
Is FlexFlow Venous Cannula recalled?
Yes. Sorin Group USA recalled FlexFlow Venous Cannula on 28 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0076-2018.
Why was it recalled?
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Which lots are affected?
Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185
Where was it sold?
Worldwide Distribution - US (nationwide) Internationally to France and Spain
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heart & Vascular Devices recalls
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| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |