Galt Medical recalls specific Tearaway Introducer Set models due to risk of luer connection cracking, which can render the dilator unusable and require replacement.
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.
Galt Medical is recalling certain Tearaway Introducer Sets because improper storage might cause the luer connection to crack or dislodge during use. This could make the dilator component unusable and require a replacement device.
The luer connection portion of the dilator hub could crack or dislodge due to improper storage conditions. This makes the dilator component unusable and requires a replacement device to continue safe use.
Medical professionals who use these specific Tearaway Introducer Sets for procedures are most at risk if the luer connection cracks during use. Patients using these devices may also be affected if the device becomes unusable.
Check for model numbers: 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. These sets were sold with specific expiration dates and lot numbers.
Identify the model number on the device to see if it matches the recalled sets listed in the recall notice.
The luer connection portion of the dilator hub could crack or dislodge due to improper storage conditions, which might render the dilator component unusable and require a replacement device.
The recall notice does not specify a remedy, so you should check the model numbers to see if your device is affected and contact Galt Medical for further instructions.
Check the model numbers on the device: 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.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1969-2023 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-1969-2023 from Galt Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
