Sorin FlexFlow Venous Cannula Recalled for Sharpness Defect
Sorin Group USA is recalling a specific lot of FlexFlow Venous Cannulas because they are sharper or pointier than expected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a physical defect (sharper/pointier than expected) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sorin Group USA, Inc. is recalling a specific lot of FlexFlow Venous Cannulas, Model/Catalog Number 200-200. The recall involves 40 units of this single-use sterile device, which is a size 23 French open lumen polymer tube used for cardiopulmonary bypass.
The recall was initiated because the specific lot of cannulas is sharper or pointier than expected. This defect presents a potential risk of injury during use. The affected units were distributed nationwide in the United States and internationally to France and Spain.
Healthcare facilities and distributors should stop using the affected FlexFlow Venous Cannulas immediately. Users should identify the product by the lot number 181185 and the UDI (01)10803622125812(240)200-200(17)200703(10)181185. Affected units should be returned to Sorin Group USA, Inc. for further instructions.
The recalled product
- 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 l
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 181185
- UDI: (01)10803622125812(240)200-200(17)200703(10)181185
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Sorin Group USA, Inc.
See all →- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
Same hazard · sharp edge
See all →- HighOBP Medical Recalls Vaginal Speculums Due to Potential Sharp Edges
FDA (Devices) · 2026-08-19
- HighMRI Machine Coil Seal Adhesive May Create Sharp Edges
FDA (Devices) · 2024-02-07
- SevereMedline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect
FDA (Devices) · 2024-01-03
- SevereMedline Nurse Training Kits Recalled for Sharp Tracheostomy Brush
FDA (Devices) · 2024-01-03
- SevereMedline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment
FDA (Devices) · 2024-01-03