Drugs & medicalClass II

Coloplast Manufacturing US, LLC recalls Ureteral dilator, REF RBD014

A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in…

Read the official notice →
Date
2024-04-10
Country
United States
Brand
Coloplast Manufacturing
Product
Ureteral dilator, REF RBD014
Classification
Class II
Units
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
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 Details may be shortened or out of date; the official notice is the authoritative source.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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