VENCLOSE — Class II medical device recall Z-0088-2023
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-10-19, distributed in CA. Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET I
| Recall number | Z-0088-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-09-01 |
| Classified | 2022-10-13 |
| Reported by FDA | 2022-10-19 |
| Terminated | 2026-01-26 |
| Distributed | CA |
| Quantity | 1,760 kits |
| UPC / GTIN / UDI-DI | 10193489423099, 40193489423090 |
| Lot numbers | 22EBV345, 22FBF358 |
| Model numbers | VC-PPH-67A |
| Expiration dates | 2024-08-31 |
Product
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0088-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.