Recall Z-0391-2019 ยท LDF Electrode, Pacemaker, Temporary
Oscor, Inc.
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the ou
| Date | Nov 8, 2018 (initiated Sep 26, 2018) |
| Status | Terminated |
| Reason | During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. |
| Root cause | Device Design |
| Action | A press release for the recall was issued on 09/27/2018. Additionally, starting on about 09/26/2018, Oscor notified customers via email and mail with a "PRODUCT RECALL - ACTION REQUIRED" letter. For distributors, instructions included to examine inventory for affected devices, quarantine any affected devices, notify customers if the affected devices have been further distributed, retrieve those affected devices from customers, and complete and return the attached Exhibit A. Any affected devices on hand and at customers should not be destroyed, but returned to Oscor. For hospitals, instru |
| Quantity | 36,688 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA. Countries of AUSTRIA, BENIN REPUBLIC, BOLIVIA, BRAZIL, BULGARIA, CANADA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADO |
| FDA record | Open on fda.gov |