Z-1127-2018 Class II Terminated
FDA device recall Z-1127-2018 was initiated by Medical Components, Inc dba MedComp on February 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 January 10, 2020). Affected quantity: 1575 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- February 23, 2018
- Termination Date
- January 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1575 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.