FDA-Device2026-02-18Class IIPACKAGING DEFECT
Medline medical kits recalled for potentially open ChloraPrep applicator seals
What this means
Medline Industries is recalling 11 different medical kits that contain BD ChloraPrep Triple Swabsticks with potentially compromised packaging seals. The affected applicators may have open or broken seals, which could affect the sterility of the product. No injuries have been reported so far.
- Check if you have any Medline kits matching the recalled SKUs (DT22010B, DT22790C, DYNDA2966A, DYNDC2208C, DYNDC3107, DYNDH1029C, UVT1250, UVT835, or VAR101HVAA)
- Match the lot number on your kit to the FDA notice
- Do not use recalled kits; contact your Medline distributor or the FDA for replacement or disposal instructions
- Verify the specific lot numbers listed in the official recall notice before discarding
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
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
21854 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2026More 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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