FDA-Device2026-02-18Class IIPACKAGING DEFECT
Medline adult catheter securement kits recalled for potentially open applicator seals
Nationwide distributionMedical devices
What this means
Medline Industries is recalling specific lots of adult catheter securement kits (SKU DYNDC3109) because the BD ChloraPrep Triple Swabstick applicators inside may have broken seals on their packaging. This could allow the sterile applicator to become contaminated.
- Check if you have lot number 25EBD613 (look for UDI 10193489918113 on the box)
- Do not use kits with this lot number
- Contact your healthcare provider or Medline for a replacement
The agency's original wording
Hazard
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1350 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2026More 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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