Z-1969-2023Class II

Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04...

Name: Z-1969-2023 Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04...
Creator: Galt Medical Corporation
Published: 2023-05-08
License: https://open.fda.gov/license/

Galt Medical Corp / initiated 2023-05-08 / Open, Classified / root cause: manufacturing process

FDA source

Galt Medical Corporation began a recall of Tearaway 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) on 2023-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1969-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-08
Posted: 2023-06-15
Recalling firm: Galt Medical Corp
Product: Tearaway 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)
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 2) Return affected product to the recalling firm. Customers with questions can email: [email protected]
Quantity in commerce: 6036
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 codes and lots: REF/UDI-DI/LOT (Expiration): INT-028-27 (OEM)/22136556(2/28/2026); INT-105-25/00841268101845/23032145(12/28/2026), 22339238(10/03/2026), 22266856(8/25/2026), 23132602(4/04/2027), 23019935(12/13/2026), 22182660(6/13/2026); INT-106-09/00841268102156/23033942(12/28/2026), 22335239(10/03/2026), 22112754(3/14/2026), 21313293(11/11/2021), 21148681(5/03/2025), 22203491(7/07/2026), 21330748(10/27/2025), 21232023(8/02/2025), 22280971(8/30/2026); INT-106-12/00841268102187/23068151(2/21/2027); INT-106-17/00841268102231/23033947 (12/06/2026), 23167613(4/03/2027); DSS-007-04 (bulk)/PRCGM047382; DSS-007-05 (bulk)/PRCGM050270; DSS-010-065 (bulk)/PRCGM040042; DSS-012-07 (bulk)/PRCGM039532, PRCGM039096

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1969-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1968-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-15
Z-1969-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-15

Product code DYB

K153533Class IITearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. / cleared 2016-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)