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

FDA Recall #Z-0898-2013 — Class II — December 13, 2012

Recall #Z-0898-2013 Date: December 13, 2012 Classification: Class II Status: Terminated

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.

Recalling Firm

Medical Components, Inc dba MedComp — Harleysville, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

785

Distribution

USA Nationwide Distribution including the state of PA.

Code Information

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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