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Terminated

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

FDA Recall Z-2104-2018 · Posted None

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDWE
Date Initiated2016-03-11
Date Terminated2019-06-07
Product Quantity19 total kits

Reason for Recall

There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.

Firm Action

Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via email to [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed to the following US states: AL, OR, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080592HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AG · 2008-09-11

Official Source

View FDA Recall →

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

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