FDAFDA · Food and drugs·Recall number Z-0937-2013
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.
Published March 20, 2013 · Recall initiated: December 17, 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
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
- Vygon Corporation
- Distributor
- Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
- 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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