Recall Z-1968-2023 ยท DYB Introducer, Catheter
Galt Medical Corporation
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
| Date | Jun 15, 2023 (initiated May 8, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process design |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer Galt Medical Corp., Jul 5, 2016 |