Medline Industries Recalls Over 21,000 Medical Kits Due to Compromised Swabstick Packaging

FDA Recalls medium FDA · · United States

Medline Industries, LP has voluntarily recalled 21,854 medical kits because they contain BD ChloraPrep Triple Swabsticks with potentially compromised packaging seals.

What Happened

Medline Industries, LP has initiated a voluntary recall for several types of medical kits and procedure trays. The recall was prompted by a determination that the BD ChloraPrep Triple Swabsticks included within these kits may exhibit open seals on the applicator packaging. This defect could potentially compromise the sterility of the swabs used in medical procedures.

Which Products Are Affected

A total of 21,854 units are included in this recall. The affected products were distributed nationwide across the United States. The specific kits, SKUs, and lot numbers are as follows:

  • UNIVERSAL KIT: SKU DT22010B, Lot 25EBC888
  • VAD ACCESS KIT: SKU DT22790C, Lots 25EBO566 and 25EBD964
  • PROCEDURE TRAY: SKU DYNDA2966A, Lots 25EBN178 and 25EBL624
  • PEDIATRIC CENTRAL LINE SMALL: SKU DYNDC2208C, Lot 25EBC706
  • PORT DRESSING KIT: SKU DYNDC3107, Lot 25EBN742
  • NON STERILE DIALYSIS KIT: SKU DYNDH1029C, Lot 25EBC778
  • UMBILICAL TRAY W/3.5&5FR CATH: SKU UVT1250, Lot 25EBO757
  • UMBILICAL VESSEL TRAY: SKU UVT835, Lot 25FMI300
  • HEMODIALYSIS TRAY: SKU VAR101HVAA, Lot 25EBE079

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected SKU and lot numbers listed above. Medline Industries, LP is notifying customers through multiple channels, including email, fax, letter, and telephone. If you possess any of the affected kits, follow the instructions provided by the manufacturer for the return or disposal of the product. For further inquiries, contact Medline Industries, LP at their Northfield, Illinois headquarters.

Why This Matters

This recall is classified as a Class II event, indicating that the use of the affected product may cause temporary or medically reversible adverse health consequences. An open seal on a sterile applicator increases the risk of contamination and subsequent infection during clinical procedures.

Source

Information provided by the FDA under recall number Z-1330-2026.

Source: FDA Official Notice

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