Medline Industries Recalls Adult Catheter Securement Dressing Kits Due to Packaging Defect

FDA Recalls medium FDA · · United States

Medline Industries, LP has voluntarily recalled 1,350 medical convenience kits because included BD ChloraPrep Triple Swabsticks may have compromised packaging seals.

What Happened

Medline Industries, LP has initiated a voluntary recall of specific medical convenience kits. The recall was prompted by a discovery that the BD ChloraPrep Triple Swabsticks included within the kits may exhibit open seals on their individual applicator packaging. This defect was originally determined by BD, the manufacturer of the swabsticks.

Which Products Are Affected

The recall affects the following medical convenience kits:

  • Product Name: ADULT CATH SECUREMENT DRSG
  • Kit SKU: DYNDC3109
  • Lot Number: 25EBD613
  • UDI/DI: 10193489918113
  • Quantity: 1,350 kits
  • Distribution: Nationwide across the United States

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBD613). Medline Industries has initiated notification through multiple channels, including email, fax, letters, and telephone. Owners of the affected kits should follow the specific instructions provided by the firm regarding the handling, return, or disposal of the compromised products.

Why This Matters

An open seal on sterile medical components like swabsticks can compromise the sterility of the device. Using non-sterile applicators in medical procedures poses a potential risk of infection to patients.

Source

Information provided by the FDA. Recall Number: Z-1327-2026.

Source: FDA Official Notice