CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 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.
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Medical Components, Inc dba MedComp
- UPC
- Lot Numbers: MCFW420, MCDD880, MCDN790, MCCK830, MCCV200, MCCX830, MCDB100, MCDT910 & MCFL210.
Units Affected
93 kits