Medline Recalls Suture Removal Trays Due to Potential Compromise of Sterile Packaging

What Happened

Medline Industries, LP has initiated a voluntary Class II recall for specific medical convenience kits. The recall was prompted by a determination that BD ChloraPrep Triple Swabsticks, which are included as components within the kits, may exhibit an open seal on the applicator packaging. This defect was identified by the component manufacturer, BD.

Which Products Are Affected

The recall involves Medline medical convenience kits distributed nationwide across the United States. A total of 2,448 kits are included in this action.

• Product Name: Medline SUTURE REMOVAL TRAY
• Kit SKU: DYNDR1277A
• UDI/DI: 10195327379308
• Lot Number: 25EBO576
• Recall Number: Z-1332-2026

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBO576). Medline Industries, LP has initiated notification to customers through various channels, including email, fax, letter, and telephone. If you possess the affected product, follow the specific instructions provided in the firm’s notification regarding the return or disposal of the kits. For further inquiries, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

An open seal on medical components intended to be sterile, such as the ChloraPrep swabsticks used in these trays, can lead to contamination. Using non-sterile components during medical procedures like suture removal increases the risk of infection for patients.

Source

This information is based on official recall data provided by the FDA.