FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline convenience kits recalled for defective adhesive tubing that may crack
What this means
Medline convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with defective tubing. The butyrate tubing in these kits may crack when used, making the adhesive unusable for medical application.
- Check your Medline kits for lot numbers 25JBU463 (ADD-A-CATH ARTNC185) or 25KBH082 (PICC DRSG TRAY DYNDC3291).
- Do not use affected kits. Contact your Medline representative or the FDA for replacement or disposal instructions.
- Report any problems with these kits to the FDA MedWatch program.
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 (6 years to 15 years)
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 kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2445-2026More 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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