Medline Industries Recalls Medical Convenience Kits Due to BD ChloraPrep Packaging Defect

What Happened

Medline Industries, LP has initiated a voluntary recall of several types of medical convenience kits. The recall was prompted by a discovery that BD ChloraPrep Triple Swabsticks included within these kits may exhibit an open seal on the applicator packaging. This defect was identified by BD and affects specific lots of Medline kits.

Which Products Are Affected

A total of 8,445 kits distributed nationwide across the United States are affected. The recall includes the following SKUs and Lot Numbers:

• LVAD Dressing Change Tray (SKU: DM320C): Lot 25EBQ881
• Port and IO Access Dressing Kit (SKU: DT15780A): Lot 25EBH827
• Port-A-Cath Dressing Change Tray (SKU: DT16615): Lot 25EBC730
• Large Bore Central Line Dressing Kit (SKU: DT19660): Lot 25EBD629
• Central Line Dressing Change Kit (SKU: DT19665): Lot 25EBU086
• Neonatal Dressing Change Kit (SKU: DT21495): Lot 25EMJ081
• NICU CVC Dressing Change Tray (SKU: DT22510A): Lot 25EMJ351
• Dressing Change Tray w/ Teg CHG (SKU: DYNDC3114B): Lot 25EBI085
• Dressing Change Kit (SKU: DYNDC3351): Lot 25EBM451

What You Should Do

Healthcare facilities and consumers should immediately inspect their inventory for the SKUs and Lot Numbers listed above. Medline Industries is notifying affected customers through various methods, including email, fax, letters, and telephone. If you have these products in your possession, you should follow the specific instructions provided by Medline regarding the return or replacement of the kits.

Why This Matters

An open seal on medical applicator packaging compromises the sterility of the device. Using non-sterile components during dressing changes or medical procedures can lead to serious infections, particularly in sensitive neonatal or surgical environments.

Source

Information provided by the FDA. Recall Number: Z-1334-2026.