Recall Z-1953-2018— Genesee BioMedical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Genesee BioMedical, Inc., initiated 2018-02-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break..
- Recalling firm
- Genesee BioMedical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-02-26
- Firm location
- Denver, CO, United States
Product description
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.
Reason for recall
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.
Data sourced from openFDA. This site is unofficial and independent of the FDA.