Galt Medical Corporation recalls Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable,…
Read the official notice →- Date
- 2023-06-21
- Country
- United States
- Brand
- Galt Medical
- Product
- Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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