Z-1120-2018 Class II Terminated

Recalled by Medical Components, Inc Dba MedComp — Harleysville, PA

FDA device recall Z-1120-2018 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: 712 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
712 kits

Product Description

12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.

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.

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

Lot Numbers: MCBS820, MCBM670, MCDY280, MCDW670, MCFX 650, MCFW520, MCCC910, MCCJ210, MCDF970, MCCV540, MCFJ340, MCFQ090 & MCFS610.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1120-2018
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.