—#196140

Product

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

FDA product code: OFF — Central Venous Catheter Tray
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: UDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024

Why it was 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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries, LP sent a MEDICAL DEVICE RECALL notice to its consignees on 09/08/2022 by US Mail. The notice identified the product, problem, and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listedon the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list thequantity of affected product you have in inventory on the form. Even if you do not have anyaffected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-131-FG Recall Code: RXXXXXXX 3.Upon receipt of your submitted response form, return labels and RGA information will beprovided, if applicable. Your account will receive credit when the returned product is received. 4.If you are a distributor, or have resold or transferred this product to another company orindividual, you are required by FDA regulations to notify them of this recall communication.Have the customers return any affected product to you for collection and return to MedlineIndustries, LP. If you have any questions, please contact the Recall Department at 866-359-1704."

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: CA

Timeline

Recall initiated: 2022-09-01
Posted by FDA: 2022-10-13
Terminated: 2026-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196140. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.