MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the reason for the recall and requested quarantine of affected products pending correction. The firm requested the completion of the response form, which upon receipt, Medline will send labels to affix to the affected products with the instructions for the consignee to remove the affected component prior to using the kit.

• FDA enforcement recordOfficial FDA database entry for Z-1041-2025
• FDA device classification · LRPOfficial 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, LP - NorthfieldSearch 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.