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Terminated

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.

FDA Recall Z-1909-2008 · Posted 2008-09-16

Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeDQX
Date Initiated2008-04-11
Date Terminated2008-10-28
Product Quantity100 units

Reason for Recall

kit contains incorrect component

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

The products were shipped to customers in PA and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031916GALT MEDICAL GUIDEWIREGalt Medical Corp. · 2003-07-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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