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U.S. Department of Health and Human Services

Class 2 Device Recall ZOLL Propadz Liquid Gel Radiolucent

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 Class 2 Device Recall ZOLL Propadz Liquid Gel Radiolucentsee related information
Date Initiated by FirmMay 28, 2019
Create DateJuly 03, 2019
Recall Status1 Terminated 3 on June 01, 2020
Recall NumberZ-1945-2019
Recall Event ID 83040
510(K)NumberK960676 
Product Classification Pulse-generator, pacemaker, external - Product Code DTE
ProductZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Code Information Lots 1719, 1719A, and 1819
Recalling Firm/
Manufacturer		 Bio-Detek, Inc.
525 Narragansett Park Dr
Pawtucket RI 02861-4323
For Additional Information ContactTechnical Support
800-348-9011
Manufacturer Reason
for Recall		Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce1789
DistributionDistributed 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTE
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