PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 6, 2013 Initiated: December 13, 2012 #Z-0898-2013

Product Description

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

Reason for Recall

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.

Details

Units Affected
785
Distribution
USA Nationwide Distribution including the state of PA.
Location
Harleysville, PA

Frequently Asked Questions

What product was recalled?
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits. Recalled by Medical Components, Inc dba MedComp. Units affected: 785.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2013. Severity: Moderate. Recall number: Z-0898-2013.