Z-2478-2015 Class III Terminated
FDA device recall Z-2478-2015 was initiated by Abbott Electrophysiology on August 12, 2015 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated September 23, 2015). Affected quantity: 86 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- August 12, 2015
- Termination Date
- September 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Model number : USAR064060; Lot code: TPR031615-01