FDA Medical Device Recalls (openFDA)
Vygon Corporation: Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
- Recall number
- Z-0937-2013
- Recalling firm
- Vygon Corporation
- Product
- Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
- Status
- Terminated
- Initiated
- 2012-12-17
- Posted
- 2013-03-11
- Terminated
- 2014-01-14
- Reason
- Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
- Root cause
- Component change control
- Action
- Churchill Medical Systems sent a letter to their consignees on December 19, 2012.
- Quantity
- 210
- Distribution
- Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
- Lot, serial or model codes
- Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.
- 510(k) numbers
- ["K081904"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 2245270
- Firm city
- Lansdale
- 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