Bio-Detek, Inc. ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Brand
Bio-Detek, Inc.
Lot Codes / Batch Numbers
Lots 1719, 1719A, and 1819
Products Sold
Lots 1719, 1719A, and 1819
Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) due to Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, IN, LA, MN, NV, OH, PA, TN, UT, WY
Page updated: Jan 10, 2026