Z-1592-2010

Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464...

Name: Z-1592-2010 Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464...
Creator: Galt Medical Corp
Published: 2010-02-08
License: https://open.fda.gov/license/

Galt Medical Corp / initiated 2010-02-08 / Terminated / root cause: packaging

FDA source

Galt Medical Corp began a recall of Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369 on 2010-02-08. The reason FDA records is "Potential problem with pouch seal thus affecting sterile product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1592-2010
Status: Terminated
Initiated: 2010-02-08
Posted: 2010-05-11
Terminated: 2011-03-21
Recalling firm: Galt Medical Corp
Product: Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Potential problem with pouch seal thus affecting sterile product.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.
Quantity in commerce: 400 units
Distribution: Nationwide Distribution -- MI, PA, IL, & Washington, D.C.
Product codes and lots: Lot F0620209

Product code DRE

K000737Class IICoaxial Dilator SetXentek Medical, Inc. / cleared 2000-08-01

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)