Recall Z-2478-2015— Abbott Electrophysiology
Class III · Terminated
Class III FDA medical device recall by Abbott Electrophysiology, initiated 2015-08-12, terminated 2015-09-23. It names one FDA 510(k) clearance: K130827. Product: 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: 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..
- Recalling firm
- Abbott Electrophysiology
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-08-12
- Terminated
- 2015-09-23
- Firm location
- Menlo Park, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.