FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: 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.
- Recall number
- Z-1909-2008
- Recalling firm
- Medical Components, Inc dba MedComp
- 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.
- Status
- Terminated
- Initiated
- 2008-04-11
- Posted
- 2008-09-16
- Terminated
- 2008-10-28
- Reason
- kit contains incorrect component
- 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
- 100 units
- Distribution
- The products were shipped to customers in PA and TX.
- Lot, serial or model codes
- Lot number MAPA870
- 510(k) numbers
- ["K031916"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 2518902
- Firm city
- Harleysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28