FDAFDA · Food and drugs·Recall number Z-1876-2013
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Published August 14, 2013 · Recall initiated: July 8, 2013
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
Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Distributor
- Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.
- Lot
- Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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