Galt Medical recalls Tearaway Introducer Kits with serial numbers KIT-010-12, KIT-010-17, KIT-900-16 due to potential luer connection cracks causing dilator hub dislodgement. Affected kits may 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 specific Tearaway Introducer Kits that could have a luer connection portion that cracks or dislodges during use. This might make the dilator component unusable and require a replacement device.
The luer connection portion of the dilator hub could crack or dislodge during use if stored improperly. This might render the dilator component unusable and require a replacement device.
Medical professionals using the Tearaway Introducer Kit for procedures are most at risk. The recall affects kits sold with specific serial numbers and expiration dates.
Check for serial numbers KIT-010-12, KIT-010-17, or KIT-900-16 on the kit. The kits have specific expiration dates listed in the recall notice.
Identify the kit's serial number from the product label to determine if it's affected.
The luer connection portion of the dilator hub could crack or dislodge during use, rendering the dilator component unusable and requiring a replacement device.
Check the kit's serial number to see if it's affected. If it is, contact Galt Medical for a replacement.
Yes, the kits have specific expiration dates listed in the recall notice, such as 2/05/2027 for some models.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1968-2023 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-1968-2023 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.
