FDA-Device2026-02-18Class IIPACKAGING DEFECT
Medline sterile resuture kits recalled for potentially open ChloraPrep swab packaging
What this means
Medline is recalling specific lots of sterile resuture packs (SKU DYNDL1980A) because the BD ChloraPrep swabsticks inside may have broken seals on their packaging. An open seal could allow the swabs to become contaminated. No injuries have been reported.
- Check if you have Medline sterile resuture kit SKU DYNDL1980A, Lot 25EBJ785
- Do not use the kit if you have this lot number
- Contact your medical supplier or Medline for a replacement or refund
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
216 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1335-2026More 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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