Reported Nov 25, 2020 · Terminated
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use…
Micro-Tech USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micro-Tech Usa · 2855 Boardwalk St · Ann Arbor, MI · 48104-6715
Is this the product you have?
- Elastic Traction Device, 11mm Lower
- UPNER56041
- Reference NumberETD-D-26-235-C-N -
- Product Usageindicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract
- Lot codes and dates
- Lots M190808231 M191018231 M191224231 M200305232
- Amount recalled
- 2420 pieces
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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