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Terminated

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

FDA Recall Z-1945-2019 · Posted None

Recalling FirmBio-Detek, Inc.
Recall StatusTerminated
Product CodeDTE
Date Initiated2019-05-28
Date Terminated2020-06-01
Product Quantity1789

Reason for Recall

Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.

Firm 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

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960676ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004Zoll Medical Corp · 1996-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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