Z-0957-2022 Class II Ongoing
FDA device recall Z-0957-2022 was initiated by Abbott on March 24, 2022 and is designated Class II. Reason for recall: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. The recall status is ongoing. Affected quantity: 588 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- March 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 588 devices
Product Description
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Reason for Recall
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Distribution Pattern
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.
Code Information
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).