FDA-Device2013-03-20Class II
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.
Vygon Corporation
Hazard
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.
Sold states
Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
Affected count
210
Manufactured in
2750 Morris Rd Ste A200, N/A, Lansdale, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2013Don't want to check this manually?
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