The Recall Desk
HighFDA (Devices)·Z-1120-2018·Announced 2018-03-28

MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk

Medical Components, Inc. is recalling 712 Tesio catheter sets because connection failures could cause blood loss or air emboli.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential blood loss or air emboli) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Medical Components, Inc. (dba MedComp) is recalling 712 units of the 12F x 40cm Tesio Catheter Set with "Y" Adaptor (Reference CMD755, UDI 884908005530). The recall is due to a potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines.

The identified defect may contribute to blood loss or air emboli in patients. The affected products were distributed worldwide, including nationwide in the United States and in various international locations such as Australia, Canada, and several European countries.

Healthcare providers and consumers should stop using the affected catheter sets immediately. The specific lot numbers involved in this recall are MCBS820, MCBM670, MCDY280, MCDW670, MCFX 650, MCFW520, MCCC910, MCCJ210, MCDF970, MCCV540, MCFJ340, MCFQ090, and MCFS610.

The recalled product

Product
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.
Manufacturer
Medical Components, Inc dba MedComp
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
712

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Medical Components, Inc dba MedComp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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