Denver, CO, United States
Genesee BioMedical, Inc. recalls
1 recall recorded since 2018, most recently on 26 February 2018. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 February 2018
- 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.
- Distribution
- Worldwide distribution. US nationwide, South Korea, Australia, COSTA RICA, Taiwan, New Zealand, Italy, Canada, Netherlands, Norway, Sweden, Switzerland, Israel, Japan, Egypt, South Africa, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1953-2018
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.