FDAFDA · Food and drugs·Recall number Z-2478-2015
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
Published September 9, 2015 · Recall initiated: August 12, 2015
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 expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Electrophysiology
- Distributor
- US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.
- Lot
- Model number : USAR064060; Lot code: TPR031615-01
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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