Z-1909-2008

CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for...

Name: Z-1909-2008 CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for...
Creator: Medical Components, Inc dba MedComp
Published: 2008-04-11
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2008-04-11 / Terminated

FDA source

Medical Components, Inc dba MedComp began a recall of CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and... on 2008-04-11. The reason FDA records is "kit contains incorrect component". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1909-2008
Status: Terminated
Initiated: 2008-04-11
Posted: 2008-09-16
Terminated: 2008-10-28
Recalling firm: Medical Components, Inc.
Product: CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
Product code: DQX Wire, Guide, Catheter
Reason for recall: kit contains incorrect component
FDA root cause: Mixed-up of materials/components
Action: The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.
Quantity in commerce: 100 units
Distribution: The products were shipped to customers in PA and TX.
Product codes and lots: Lot number MAPA870

Product code DQX

K031916Class IIGalt Medical GuidewireGalt Medical Corp. / cleared 2003-07-17

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)