The Recall Desk
HighFDA (Devices)·Z-1557-2022·Announced 2022-08-24

Echelon-14 Micro Catheter Recall Due to Moisture Exposure During Transport

Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.

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: This is a sterile medical device recall where moisture exposure to packaging presents a risk of harm through potential loss of sterility or device function. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Micro Therapeutics, Inc. is recalling the Echelon-14 Micro Catheter (Reference 105-5092-150) due to moisture exposure of the outer carton packaging during transport. The recalled lot is B262322, affecting two units.

The Echelon-14 Micro Catheter is a sterile medical device used in interventional procedures. Moisture exposure to the outer carton packaging can compromise the sterility and integrity of the device.

If you have received one of these devices, contact your healthcare provider or Micro Therapeutics, Inc. for instructions on what to do next. Do not use the device if it remains unopened or in inventory.

The recalled product

Product
Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
Manufacturer
Micro Therapeutics, Inc.
Category
Medical Device
Hazard
  • moisture-exposure
  • device-contamination

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 (1)

  • Lot # B262322 UDI: (00) 847536005983

Distribution

Distributed nationwide across the United States.

Related recalls

Same category