FDAFDA · Food and drugs·Recall number Z-0898-2013
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Published March 6, 2013 · Recall initiated: December 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Components, Inc dba MedComp
- Distributor
- USA Nationwide Distribution including the state of PA.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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