CLASS II ONGOING Device recall · Reported 21 Jun 2023 · FDA Enforcement Report
Tearaway Introducer Set recalled by Galt Medical
Galt Medical is recalling Tearaway Introducer Set, distributed nationwide in the US. The recall was initiated on 8 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1969-2023
- FDA event ID
- 92322
- Recalling firm
- Galt Medical, Garland, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 May 2023
- FDA classified
- 15 Jun 2023
- Reported
- 21 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 8 May 2023 | Recall initiated by company | |
| 15 Jun 2023 | Classified by FDA | +38 days |
| 21 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
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.
Nationwide CaliforniaFloridaGeorgiaMassachusettsNew JerseyNevadaNew YorkOhioPennsylvaniaUtah
Questions about this recall
Is Tearaway Introducer Set recalled?
Yes. Galt Medical recalled Tearaway Introducer Set on 8 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-1969-2023.
Why was it 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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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