FDA Device recall Z-0532-2025
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile by Medline Industries Northfield, citing some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0532-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-15 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Reason
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Identifiers
| code_info | (1) REF CDS840132O - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277; (2…(1) REF CDS840132O - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277; (2) REF DYNJ903016G - Lot numbers 24DBP801, exp. 8/31/2025; and 24CBJ749, exp. 11/30/2024, UDI-DI each - 10195327657154, UDI-DI case - 40195327657155. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0532-2025%22
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