Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Reported: June 21, 2023 Initiated: May 8, 2023 #Z-1968-2023
Product Description
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Reason for Recall
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.
Details
- Recalling Firm
- Galt Medical Corporation
- Units Affected
- 490
- Distribution
- 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, NO.
- Location
- Garland, TX
Frequently Asked Questions
What product was recalled? ▼
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16. Recalled by Galt Medical Corporation. Units affected: 490.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2023. Severity: Moderate. Recall number: Z-1968-2023.
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