Z-1644-2019 Class II Terminated
FDA device recall Z-1644-2019 was initiated by Maquet Cardiovascular, LLC on April 18, 2019 and is designated Class II. Reason for recall: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path b… The recall status is terminated (terminated July 28, 2025). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- April 18, 2019
- Termination Date
- July 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
Reason for Recall
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Distribution Pattern
Nationwide
Code Information
Batch Numbers: 3000080434 3000081004