Recall Z-1357-2020— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2020-01-21, terminated 2023-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180. Reason: The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-21
- Terminated
- 2023-01-12
- Firm location
- Northfield, IL, United States
Product description
Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
Reason for recall
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.