Z-0088-2023Class II

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

Name: Z-0088-2023 VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-09-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-09-01 / Terminated

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit on 2022-09-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0088-2023
Classification: Class II
Status: Terminated
Initiated: 2022-09-01
Posted: 2022-10-13
Terminated: 2026-01-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Product code: OFF Central Venous Catheter Tray
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
FDA root cause: Under Investigation by firm
Action: 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."
Quantity in commerce: 1760 kits
Distribution: CA
Product codes and lots: UDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0088-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0088-2023	Class II	Terminated	Voluntary: Firm initiated	2022-10-19	2022-10-13

Product code OFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)