Recall Z-1945-2019
Bio-Detek, Inc. · initiated May 28, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Codes / lots: Lots 1719, 1719A, and 1819
Reason for recall
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
FDA-determined 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
Details
- Recall number
- Z-1945-2019
- Initiated
- May 28, 2019
- Terminated
- June 1, 2020
- Product code
- DTE – Pulse-Generator, Pacemaker, External
- 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.
- Recalling firm
- Bio-Detek, Inc., Pawtucket, RI