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.
FDA Recall Z-1953-2018 · Posted None
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Recalling FirmGenesee BioMedical, Inc.
Recall StatusOpen, Classified
Product CodeDWS
Date Initiated2018-02-26
Product Quantity444 units
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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