Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
FDA Recall Z-2106-2018 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.