Recall Z-2106-2018
Datascope Corporation · initiated March 11, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
Codes / lots: Batch Number 3000018640, UDI Code 10607567205373; Batch Number 3000020516, UDI Code 10607567205373
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 fieldactions@maquet.com.
Details
- Recall number
- Z-2106-2018
- Initiated
- March 11, 2016
- Terminated
- June 7, 2019
- Product code
- DWE – Tubing, Pump, Cardiopulmonary Bypass
- Quantity
- 19 total kits
- Distribution
- The products were distributed to the following US states: AL, OR, and TX.
- Recalling firm
- Datascope Corporation, Fairfield, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2104-2018 Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588There is a potential problem with the cuvette where failure of the cuvette would cause an error message on… | 03/11/2016Terminated |
| Z-2105-2018 Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part…There is a potential problem with the cuvette where failure of the cuvette would cause an error message on… | 03/11/2016Terminated |