Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
FDA device recall Z-1968-2023 · posted 2023-06-15 · Open, Classified
Recall details
- Recalling firm
- Galt Medical Corporation
- 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.
- Action taken
- On 5/5/23, recall notices were sent to customers who were asked to do the following: 1) Identify and segregate the affected lot(s) that are in your possession as well as those in the possession of your end-users. 2) Complete and return the field correction reply form to quality@galtmedical.com 2) Return affected product to the recalling firm. Customers with questions can email: dderrick@galtmedical.com
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- DYB
- Quantity 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.
- Date initiated
- 2023-05-08
- Date posted
- 2023-06-15
- Location
- Garland, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (K153533) | Galt Medical Corp. | 2016-07-05 |