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U.S. Department of Health and Human Services

Class 2 Device Recall 12F MODIFIED Tesio CATHETER SET

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  Class 2 Device Recall 12F MODIFIED Tesio CATHETER SET see related information
Date Initiated by Firm February 23, 2018
Create Date March 19, 2018
Recall Status1 Terminated 3 on January 10, 2020
Recall Number Z-1123-2018
Recall Event ID 79436
510(K)Number K022570  
Product Classification Kit, repair, catheter, hemodialysis - Product Code NFK
Product 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259

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.
Code Information Lot Numbers: MCBM830, MCDZ620 & MCDP130.
Recalling Firm/
Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact Susan Smith
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On February 23, 2018, Medcomp distributed Product Recall and Distribution notices to international distributors via email and to U.S. facilities via courier service on February 26, 2018. Medcomp is requesting the return of all un-used affected product. Customers should immediately examine inventory and quarantine product subject to recall. If for any reason the product was further distributed, please identify the recipients and notify them at once of this product recall. Your notification may be enhanced by including a copy of this recall notification letter. Contact your customer service representative for a Returned Goods Authorization number if necessary by calling (215) 256-4201. Complete and return the Distribution Notice via fax (215-256-9191) or email (complaints@medcompnet.com.
Quantity in Commerce 40 kits
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NFK and Original Applicant = MEDCOMP