Medline Industries Recalls Mercy Circumcision Trays Due to Compromised Packaging

What Happened

Medline Industries, LP has initiated a voluntary recall of specific medical convenience kits. The recall was triggered after it was determined that BD ChloraPrep Triple Swabsticks included within the kits may exhibit an open seal on the packaging of the applicators. This defect was identified by BD, the manufacturer of the swabsticks.

Which Products Are Affected

The recall affects the Medline medical convenience kit packaged as the MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B.

Specific details for the affected units include:

• Quantity: 168 units
• Lot Number: 25EBC648
• UDI/DI: 10653160990666
• Recall Number: Z-1336-2026
• Distribution: Nationwide across the United States

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBC648). Medline has initiated notification through various methods, including email, fax, letter, and telephone. If you possess the affected kits, you should follow the instructions provided in the firm’s notification for the return or disposal of the product. For additional information, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

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

Source

Information provided by the FDA.