Reported Apr 3, 2013 · Terminated
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface…
Biosense Webster, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Biosense Webster, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
20-Pole Eco CableCatalog #EM-5050-060
- Product UsageThe 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System
- Lot codes and dates
- Impacted serial Numbers
12013213413615134235035435636336837337938038438540240542491995395496096396897097798099399810011123114813781596172917451747174917501751175317541758175917601761179717991802180318041805
- Lot Numbers
P1210P1220P1221P1231
- Impacted serial Numbers
- Amount recalled
- 54 units
Where it was sold
- Nationwide
- DE
Why it was recalled
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
This product could cause temporary or reversible health problems — stop using it.
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