Medline Industries Recalls Blood Culture Kits Over Potential Packaging Seal Breach

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 contained within these kits may exhibit an open seal on the applicator packaging. This defect was identified by BD and affects kits assembled and distributed by Medline.

Which Products Are Affected

The recall involves approximately 4,300 kits distributed nationwide across the United States. The specific products affected are:

• Product Name: Medline medical convenience kits (BLOOD CULTURE KIT NS)
• Kit SKU: DYNDH2088
• UDI/DI: 10198459230363
• Lot Numbers: 25EBU508 and 25EBE330

What You Should Do

Medline Industries is notifying affected customers through multiple channels, including email, fax, letters, and telephone calls. Healthcare providers and facilities should immediately check their inventory for the specified lot numbers. If affected products are found, users should follow the instructions provided in the firm’s notification regarding the return or disposal of the kits. For further inquiries, customers can contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

An open seal on medical applicator packaging can compromise the sterility of the device. Using non-sterile swabsticks during medical procedures increases the risk of patient infection or contamination of blood cultures, which can lead to inaccurate diagnoses or improper treatment.

Source

Information provided by the FDA. Recall Number: Z-1333-2026.