Recall Z-0782-2021— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2020-11-13, terminated 2021-10-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The cylindrical sponge component is not x-ray detectable..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-13
- Terminated
- 2021-10-26
- Firm location
- Northfield, IL, United States
Product description
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.
Reason for recall
The cylindrical sponge component is not x-ray detectable.
Data sourced from openFDA. This site is unofficial and independent of the FDA.