Recalls / —
—#184627
Product
Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
- FDA product code
- LRO — General Surgery Tray
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lot 20FBW645 (Expiration: 02/28/2022); Lot 20HBM397 (Expiration: 02/28/2022)
Why it was recalled
The cylindrical sponge component is not x-ray detectable.
Root cause (FDA determination)
Process control
Action the firm took
Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time. No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected.
Recalling firm
- Firm
- Medline Industries Inc
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- Foreign distribution only - Canada.
Timeline
- Recall initiated
- 2020-11-13
- Terminated
- 2021-10-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #184627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.