Recall Z-1953-2018 ยท DWS Instruments, Surgical, Cardiovascular
Genesee BioMedical, Inc.
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.
| Date | Feb 26, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | The customer communication letter, dated February 26, 2018, was mailed or emailed. The letter describes the concern and the user action. A copy of the revised Instructions for Use will be provided with the letter. All consignees in the US and outside of the US who have not been previously contacted will receive notification. |
| Quantity | 444 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.