FDA Device recall Z-1358-2020
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350 by Medline Industries, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1358-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-21 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medline Industries |
| Distribution | CA |
Product
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
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.
Identifiers
| code_info | REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1358-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.