Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2322-2023.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2322-2023.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medline Industries, Lp - Northfield or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2322-2023.
MEDLINE INDUSTRIES, LP - Northfield
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Medline Industries, Lp - Northfield Recall FAQ
Medline Industries, Lp - Northfield is the subject of a medical implants safety report: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE.... The notice was published on May 15, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 134,514 units are potentially affected.