Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Read the official notice →- Date
- 2025-04-02
- Country
- United States
- Brand
- Merit Medical Systems
- Product
- Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Classification
- Class II
- Units
- International distribution to the country of Japan.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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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