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.
- Company
- Medline Industries Inc
- Recall Initiated
- November 13, 2020
- Terminated
- October 26, 2021
- Recall Number
- Z-0782-2021
- Quantity
- 45
- Firm Location
- Northfield, IL
Reason for Recall
The cylindrical sponge component is not x-ray detectable.
Distribution
Foreign distribution only - Canada.
Lot / Code Info
Lot 20FBW645 (Expiration: 02/28/2022); Lot 20HBM397 (Expiration: 02/28/2022)
Root Cause
Process control
Action Taken
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.