FDA-Device2013-03-06Class II

REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

Medical Components, Inc dba MedComp
Hazard

The affected 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
USA Nationwide Distribution including the state of PA.
Affected count
785
Manufactured in
1499 Delp Dr, N/A, Harleysville, PA, United States
Products
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0898-2013

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