Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VENCLOSE Recalled by MEDLINE INDUSTRIES, LP - Northfield Due to Impacted Venclose Procedure Packs contain a 12cm introducer/sheath...

Date: September 1, 2022
Company: MEDLINE INDUSTRIES, LP - Northfield
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MEDLINE INDUSTRIES, LP - Northfield directly.

Affected Products

VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

Quantity: 1760 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About MEDLINE INDUSTRIES, LP - Northfield

MEDLINE INDUSTRIES, LP - Northfield has 822 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report