FDAFDA · Food and drugs·Recall number Z-1023-2013
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Published April 3, 2013 · Recall initiated: March 5, 2013
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biosense Webster, Inc.
- Distributor
- Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.
- Lot
- Impacted serial Numbers: 120, 132, 134,136, 151, 342, 350, 354, 356, 363, 368, 373, 379, 380, 384, 385, 402, 405, 424, 919, 953, 954, 960, 963, 968, 970, 977, 980, 993, 998, 1001, 1123, 1148, 1378, 1596, 1729, 1745, 1747, 1749, 1750, 1751, 1753, 1754, 1758, 1759, 1760, 1761, 1797, 1799, 1802, 1803, 1804, 1805. Lot Numbers: P1210, P1220, P1221, P1231.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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