Recall Z-0088-2023— MEDLINE INDUSTRIES, LP - Northfield
Class II · Terminated
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-09-01, terminated 2026-01-26. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-09-01
- Terminated
- 2026-01-26
- Firm location
- Northfield, IL, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.