Reported Jun 6, 2018 · Ongoing
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1…
Genesee BioMedical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genesee BioMedical, Inc. · 700 W Mississippi Ave Unit D5 · Denver, CO · 80223-4509
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
445 of 445 codes
114411457077099594041114115152062178411565426944524559404335609417183889608081045100747948447339010671071469470105497762696749411404507831194853920273368112011211126770773949950475102110221159877680
- Serial Numbers
- Amount recalled
- 444 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Genesee BioMedical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.