FDA Medical Device Recalls (openFDA)
Bio-Detek, Inc.: ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
- Recall number
- Z-1945-2019
- Recalling firm
- Bio-Detek, Inc.
- Product
- ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
- Status
- Terminated
- Initiated
- 2019-05-28
- Posted
- not on file
- Terminated
- 2020-06-01
- 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.
- Lot, serial or model codes
- Lots 1719, 1719A, and 1819
- 510(k) numbers
- ["K960676"]
- PMA numbers
- not on file
- Product code
- DTE
- Firm FEI
- 1218058
- Firm city
- Pawtucket
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28