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Micro-Tech Usa recalls Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use
Recalled November 25, 2020 · FDA recall Z-0470-2021 · Micro-Tech Usa
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. · FDA Class II
Units
2420 pieces
Sold at
US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.
Description
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.
Product
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.
Manufacturer(s)
Micro-Tech Usa
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →