FDA-Device2026-02-18Class IIPACKAGING DEFECT
Medline medical convenience kits recalled for potentially open BD ChloraPrep applicator seals
Nationwide distribution
Check your Medline dressing change kits for seal damage
Medline is recalling nine different medical convenience kits that contain BD ChloraPrep Triple Swabsticks with potentially compromised packaging seals. The affected applicators may have open or damaged seals, which could allow contamination. About 8,445 kits are involved nationwide.
- Check if you have any of the nine affected Medline kits (SKU numbers: DM320C, DT15780A, DT16615, DT19660, DT19665, DT21495, DT22510A, DYNDC3114B, or DYNDC3351)
- Do not use any kits with the recalled lot numbers
- Contact Medline or your supplier for replacement kits
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.
Sold states
US Nationwide distribution.
Affected count
8445 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1334-2026More Medline Industries, LP recalls
- FDA-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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