Drugs & medicalClass II

PACIFIC LASERTECH, LLC recalls 25-LHP-928, HeNe Laser System, 25 mW

These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall…

Read the official notice →
Date
2024-09-18
Country
United States
Brand
PACIFIC LASERTECH, LLC
Product
25-LHP-928, HeNe Laser System, 25 mW
Classification
Class II
Units
US Nationwide Distribution
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 Details may be shortened or out of date; the official notice is the authoritative source.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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