Medline Industries Recalls Sterile Resuture Packs Due to Potential Packaging Seal Defect

What Happened

Medline Industries, LP has issued a voluntary, firm-initiated recall for specific medical convenience kits. The recall was prompted by a discovery that BD ChloraPrep Triple Swabsticks included within the kits may exhibit an open seal on the applicator packaging. This defect was identified by BD and affects the integrity of the sterile components within the Medline kits.

Which Products Are Affected

The recall involves Medline medical convenience kits distributed nationwide across the United States. A total of 216 kits are included in this action.

• Product Name: Medline medical convenience kits packaged as: STERILE RESUTURE PACK
• Kit SKU: DYNDL1980A
• UDI/DI: 10195327379292
• Lot Number: 25EBJ785
• Recall Number: Z-1335-2026

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBJ785). Medline Industries has initiated notification through multiple channels, including email, fax, letter, and telephone. Affected products should be quarantined and handled according to the instructions provided by Medline Industries, LP. For further information regarding returns or replacements, contact Medline Industries directly at their Northfield, IL headquarters.

Why This Matters

An open seal on medical components intended to be sterile, such as swabsticks, can lead to contamination. Using non-sterile components in a resuture pack poses a risk of infection to patients during medical procedures.

Source

Information provided by the FDA.