Micro-Access Tearaway Introducer Kit recallZ-1968-2023 · Galt Medical Corporation · initiated May 8, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Galt Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process design
What the company is doing
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 [email protected] 2) Return affected product to the recalling firm. Customers with questions can email: [email protected]
Recall details
- Recall number
- Z-1968-2023
- Status
- Open, Classified
- Initiated by the company
- May 8, 2023
- Posted by the FDA
- Jun 15, 2023
- Recalling firm
- Galt Medical Corporation
- Quantity
- 490
- Product code
- DYB
- FDA submissions
- K153533
- 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.
Product description
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Code information (models, lots, serial numbers)
REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027), S22356870(1/11/2027); KIT-010-17/00841268105249/S23083725(2/05/2027), S22231321(9/08/2026), S22328872(1/18/2027); KIT-900-16/S22308637(1/04/2027)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Micro-Access Tearaway Introducer Kit KIT-010-12Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
- Micro-Access Tearaway Introducer Kit KIT-010-17Galt Medical Corp. · Percutaneous Sheath Introducer Kit1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92322).
- Z-1969-2023 · Open, ClassifiedTearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page