MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ82437A; 5) C LINE INSERTION CDS, Model Number: CDS980379J; 6) BSHR PICC LINE-LF, Model Number: DYNJ24529M; 7) ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; 8) PICC LINE PACK, Model Number: DYNJ55170F; 9) LINE INSERTION PACK, Model Number: DYNJ44949C; 10) RFA PACK, Model Number: DYNJ67899A; 11) KIT CENTRAL LINE INSERTION-LF, Model Number: PHS902533005; 12) INFANT LUMBAR PUNCTURE TRAY, Model Number: DYNDH1904; 13) PICC PACK-LF, Model Number: DYNJ55356A; 14) GENERAL TRAY, Model Number: DYNJ15652M; 15) CVR ENDOVENOUS PACK, Model Number: DYNJ80643; 16) LINE INSERTION TRAY, Model Number: DYNJ20803D

An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

• FDA enforcement recordOfficial FDA database entry for Z-1593-2025
• FDA device classification · OFFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1140The 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.