Galt Medical Corporation 2023-06-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1968-2023
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 Recall
Issued June 21, 2023 · Galt Medical Corporation
In June 2023, Galt Medical Corporation recalled the Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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, and can require the use of a replacement device.
What you should do
- 1 Stop using Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Galt Medical Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Galt Medical Corporation
- Category
- Health
- Recall date
- June 21, 2023
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH,
- Recall number
- FDA-Z-1968-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Galt Medical Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.