Reported Sep 9, 2015 · Terminated
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060…
Abbott Electrophysiology
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Electrophysiology · 1530 Obrien Dr · Menlo Park, CA · 94025-1454
Is this the product you have?
- FIRMap 60mm Catheter
- Size
60 mmLength 50.4
- inches French Size Diameter8.5F (2.84mm)
- Model numberUSAR064060 Sterile
- Rx only CardiovascularFor use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone
- Lot codes and dates
- Model numberUSAR064060
- Lot codeTPR031615-01
- Amount recalled
- 86 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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