The Recall Desk
HighFDA (Devices)·Z-1953-2018·Announced 2018-06-06

Genesee BioMedical Sternal Valve Retractors Recalled for Corrosion-Related Blade Failure

Genesee BioMedical is recalling 444 Sternal Valve Retractors used in cardiac surgery due to corrosion that may cause the bearing or button to break.

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 used in cardiac surgery where a mechanical failure (blade breakage) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Genesee BioMedical, Inc. is recalling 444 units of Sternal Valve Retractors With Atrial and Aortic Rakes. The affected models are SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1, and CSR-AR. These devices are intended for use in cardiac surgery.

The recall is due to a failure in the retractor blade caused by corrosion. Corrosion can form in the area where the bearing or button meets the blade body, which weakens the welded joint. This weakening may cause the bearing or button to break.

The affected units were distributed worldwide, including in the United States, South Korea, Australia, Costa Rica, Taiwan, New Zealand, Italy, Canada, the Netherlands, Norway, Sweden, Switzerland, Israel, Japan, Egypt, South Africa, and the United Kingdom. Healthcare facilities and consumers should stop using these devices and contact Genesee BioMedical for instructions on return or replacement.

The recalled product

Product
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
Manufacturer
Genesee BioMedical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
444

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · corrosion

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