Drug recall
Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
FDA recall event 84908 · Class II · Medline Industries Inc
Key facts
| Event ID | 84908 |
|---|---|
| Recall numbers | Z-1357-2020, Z-1358-2020 |
| Recalling firm | Medline Industries Inc |
| Product type | Devices |
| Products | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180, Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jan 21, 2020 |
| Report date | Mar 4, 2020 |
| Termination date | Jan 12, 2023 |
| City | Northfield |
| State | IL |
| Country | United States |
| FEI number | 1417592 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: