FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline pediatric dressing change kit recalled for defective adhesive tubing
What this means
Medline's pediatric dressing change convenience kit contains a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with a manufacturing defect. The tubing may crack when you try to use it, making the adhesive unusable.
- Check if you have kit model DYNDC3359, lot numbers 25KBK310 or 25LBN341.
- Do not use the kit if you have an affected lot.
- Contact Medline or your supplier for a replacement or refund.
The agency's original wording
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Intended for
Children
Illnesses reported
None reported
Sold states
US Nationwide distribution. OUS distribution pending.
Affected count
49,654 kits total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2426-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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