Z-1945-2019Class II

ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

Name: Z-1945-2019 ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Creator: Bio-Detek, Inc.
Published: 2019-05-28
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2019-05-28 / Terminated / root cause: manufacturing process

FDA source

Bio-Detek, Inc. began a recall of ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) on 2019-05-28. FDA classified it as Class II and gives the reason as "Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1945-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2019-07-03
Terminated: 2020-06-01
Recalling firm: ZOLL Medical Corporation
Product: ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Product code: DTE Pulse-Generator, Pacemaker, External
Reason for recall: Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lots 1719, 1719A, and 1819

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1945-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03

Product code DTE

K960676Class IIZoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004Zoll Medical Corp / cleared 1996-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)