FDAFDA · Food and drugs·Recall number Z-0470-2021
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
Published November 25, 2020 · Recall initiated: October 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro-Tech Usa
- Distributor
- US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.
- Lot
- Lots M190808231 M191018231 M191224231 M200305232
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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