Drugs & medicalClass II

Stradis Medical, LLC dba Stradis Healthcare recalls Foundation Kit

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Read the official notice →
Date
2021-10-27
Country
United States
Brand
Stradis Medical, LLC dba Stradis Healthcare
Product
Foundation Kit
Classification
Class II
Units
Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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