Z-1311-04

Merit MAK Mini Access Kit, 4 French (1.3mm)

Name: Z-1311-04 Merit MAK Mini Access Kit, 4 French (1.3mm)
Creator: Merit Medical Systems, Inc
Published: 2004-07-20
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2004-07-20 / Terminated

FDA source

Merit Medical Systems, Inc began a recall of Merit MAK Mini Access Kit, 4 French (1.3mm) on 2004-07-20. The reason FDA records is "Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1311-04
Status: Terminated
Initiated: 2004-07-20
Posted: 2004-08-04
Terminated: 2005-01-21
Recalling firm: Merit Medical Systems, Inc.
Product: Merit MAK Mini Access Kit, 4 French (1.3mm)
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
FDA root cause: Other
Action: Consignees were notified by phone and letter on 7/20/2004.
Quantity in commerce: 634 kits
Distribution: Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.
Product codes and lots: Catalog Number MAK405, Lot Numbers:G338462, M9337638, MR314387, MR317165, MR320060.

Product code DRE

K031691Class IIMerit Mak (Mini Access Kit)Merit Medical Systems, Inc. / cleared 2003-09-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)