Z-0436-2019 Class I Terminated
FDA device recall Z-0436-2019 was initiated by Maquet Cardiovascular Us Sales, Llc on Oct 25, 2018 and is designated Class I. Reason for recall: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or… The recall status is terminated (terminated Jun 5, 2020). Affected quantity: 490 total in US.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 5, 2018
- Initiation Date
- Oct 25, 2018
- Termination Date
- Jun 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 490 total in US
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France, United Kingdom, Ireland, Italy, Lebanon, Netherlands, Pakistan, Portugal, Reunion, Saudi Arabia, Sweden, South Africa, Poland, Serbia, Russia, Turkey, Ukraine, China, India, Japan, Republic of Korea (South Korea), Malaysia, Thailand, and Taiwan.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0436-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026