FDAFDA · Food and drugs·Recall number Z-0957-2022
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Published April 27, 2022 · Recall initiated: March 24, 2022
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
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott
- Distributor
- Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.
- Lot
- Lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. UDI (01)05415067027634(17)230331(10)xxxxxxx (lot number).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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