Z-1123-2018 Class II Terminated
FDA device recall Z-1123-2018 was initiated by Medical Components, Inc Dba MedComp on Feb 23, 2018 and is designated Class II. Reason for recall: There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. The recall status is terminated (terminated Jan 10, 2020). Affected quantity: 40 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 28, 2018
- Initiation Date
- Feb 23, 2018
- Termination Date
- Jan 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 kits
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
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-1123-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026