ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
This recall has been terminated (originally issued May 28, 2019).
- Company
- Bio-Detek, Inc.
- Recall Initiated
- May 28, 2019
- Terminated
- June 1, 2020
- Recall Number
- Z-1945-2019
- Quantity
- 1789
- Firm Location
- Pawtucket, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
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.
Lot / Code Info
Lots 1719, 1719A, and 1819
Root Cause
Process control
Action Taken
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