Class 2 Device Recall MEDLINE

• Date Initiated by Firm: April 22, 2024
• Date Posted: May 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1938-2024
• Recall Event ID: 94537
• 510(K)Number: K061275
• Product Classification: Syringe, piston - Product Code FMF
• Product: MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
• Code Information: UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline Industries, LP, issued a recall notice to its consignees on 04/22/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested that the affected product be destroyed.
• Quantity in Commerce: 5,075,234 syringes
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMF