Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) EXTREMITY PACK

Convenience kits labeled as sterile have not gone through the sterilization process.

Customers were alerted via email and telephone beginning 8/8/25 of a potential issue with the products. An URGENT MEDICAL DEVICE RECALL notification letter dated 8/22/25 was sent to customers. This communication is a follow-up to the notification you received from your Medline Sales Representative and to acknowledge the subsequent return of impacted product to Medline. This communication is to provide formal documentation of the recall for your records. No additional action is required to be taken. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Sterile Medline Convenience Kits. It has been identified that specific convenience kits labeled as sterile have not gone through the sterilization process. As a result, these kits are non-sterile. If the non-sterile kits are assumed sterile upon use, this could result in potential contamination of the sterile-field and an increased risk of patient infection that may require the use of intravenous or oral antibiotics. Refer to the enclosed list for all affected item number(s) and affected lot number(s). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax and to Medline Industries, LP. If you have any questions regarding this notification, please contact the Director, Regulatory Compliance at (smbrandel@medline.com). or Product Recall Specialist at HBarclay@Medline.com.

• FDA enforcement recordOfficial FDA database entry for Z-2593-2025
• FDA device classification · OJHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medline Industries, LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.