Recall Z-1945-2019 ยท DTE Pulse-Generator, Pacemaker, External
Bio-Detek, Inc.
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
| Date | May 28, 2019 |
| Status | Terminated |
| Reason | Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy. |
| Root cause | Process control |
| Action | The firm notified customers of the recall on May 28, 2019, via Urgent Device Correction letter. Customers were advised to take the following actions: - Inform users of the problem. -Remove all stock of part numbers 8900-2105-01 and 8900-2106-01 with lot numbers 1719, 1719A , and 1819. - Complete the response form and return to ZOLL. A ZOLL representative will contact you to coordinate the return and replacement of your electrodes. Customers may direct their questions to the firm's 24/7 technical support numbers 1 (800) 348-9011 or +1(978)421-9460 |
| Quantity | 1789 |
| Distribution | Distributed to accounts in AZ, CA, CO, CT, FL, LA, MN, NV, OH, PA, TN, UT, and WY. International distribution to Canada, Germany, France, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960676 | ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 Zoll Medical Corp, Jun 5, 1996 |