FDA Device recall Z-0088-2023
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit
- FDA Device
- Class II
- terminated
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit by Medline Industries Northfield, citing impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FI….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0088-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-01 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | CA |
Product
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Reason
Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018
Identifiers
| code_info | UDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0088-2023%22
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