FDA Medical Device Recalls (openFDA)
Galt Medical Corporation: Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
- Recall number
- Z-1968-2023
- Recalling firm
- Galt Medical Corporation
- Product
- Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
- Status
- Open, Classified
- Initiated
- 2023-05-08
- Posted
- 2023-06-15
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K153533"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3000718472
- Firm city
- Garland
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28