FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline dressing change and driveline management kits recalled for defective adhesive tubing
What this means
Medline convenience kits (Driveline Management Kit EBSI1688 and Port Dressing Change Kit EBSI1328A) contain a recalled adhesive product with defective tubing. The tubing may crack when used, making the adhesive unusable. About 49,600 kits have been distributed nationwide.
- Check if you have either kit: EBSI1688 (Lot 2025102890) or EBSI1328A (Lot 2025103090)
- Do not use the kits if the tubing appears cracked or damaged
- Contact Medline or your healthcare provider for a replacement
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
Adults
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: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2440-2026More 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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