Medline Industries, LP has recalled 270,311 convenience kits, including various surgical, angiography, and catheterization packs, due to unapproved design changes made to the 10mL polycarbonate colored syringes inside them. These changes were made without the necessary FDA clearance, which ensures the devices meet safety and performance standards. Consumers should check for a wide range of affected products used in medical procedures, such as Angio Packs, Cath Lab Packs, and Heart Failure Packs, distributed worldwide including the United States, Canada, Panama, and Barbados. While no incidents or injuries have been reported, Medline is initiating this voluntary recall to correct the unapproved modifications.
Risk
The syringes within these kits underwent design changes that were not reviewed or cleared by the FDA, meaning their safety, effectiveness, and compatibility with medical procedures have not been officially verified. Using unapproved medical components during sensitive procedures like angiography or catheterization could potentially lead to device failure or patient complications.
What You Should Do
Identify if you have any of the affected Medline Convenience Kits by checking the product name and SKU on your medical supply inventory. Affected kits include various Angiography, Cath Lab, Surgery, and specialty procedure packs.
Check the specific Catalog Number (DYNJ prefix), UDI-DI, and Lot Number printed on the device label or outer carton of the kit. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.
Your Remedy Options
📋Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
Sold By: Authorized Medical Distributors; Direct Sales to Hospitals
Manufactured In: United States
Units Affected: 17 products (270,311 total)
Distributed To: Nationwide
Were You Affected by This Recall?
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.
