Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3033-2024
• Recall Event ID: 94583
• 510(K)Number: K103830
• Product Classification: Syringe, piston - Product Code FMF
• Product: Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM0004; 4) SYR 10ML L/S, Pack Number OEM11623 ; 5) JAPAN 3ML SYRINGE , Pack Number SAMPCJ006; 6) JAPAN 5ML SYRINGE, Pack Number SAMPCJ007; 7) JAPAN 10ML SYRINGE, Pack Number SAMPCJ008; 8) JAPAN 20ML SYRINGE, Pack Number SAMPCJ009; 9) JAPAN 30ML SYRINGE, Pack Number SAMPCJ010; 10) JAPAN 60ML SYRINGE, Pack Number SAMPCJ011
• Code Information: DYNJSYCPP10R , Lot Number 22JBR164 ; DYNJSYCPP10Y , Lot Number 22JBR165 ; NAM0004, Lot Number 21DDB223 ; NAM0004, Lot Number 21HDC569 ; NAM0004, Lot Number 21IDB793 ; NAM0004, Lot Number 21JDA347 ; NAM0004, Lot Number 21LDA148 ; OEM11623 , Lot Number 21GBQ995 ; OEM11623 , Lot Number 22BBC557 ; OEM11623 , Lot Number 22CBH284 ; OEM11623 , Lot Number 19BBF348 ; OEM11623 , Lot Number 19DBI184 ; OEM11623 , Lot Number 22EBE833 ; OEM11623 , Lot Number 19QBB707 ; OEM11623 , Lot Number 19FBK375 ; OEM11623 , Lot Number 19GBY960 ; OEM11623 , Lot Number 19HBH787 ; OEM11623 , Lot Number 19HBO770 ; OEM11623 , Lot Number 23ABH043 ; OEM11623 , Lot Number 19KBX346 ; OEM11623 , Lot Number 19LBK179 ; OEM11623 , Lot Number 20BBC515 ; OEM11623 , Lot Number 20BBS501 ; OEM11623 , Lot Number 20CBB499 ; OEM11623 , Lot Number 20CBB674 ; OEM11623 , Lot Number 20FBA919 ; OEM11623 , Lot Number 20HBT942 ; OEM11623 , Lot Number 20LBK683 ; OEM11623 , Lot Number 20XBD345 ; OEM11623 , Lot Number 21FBG914 ; SAMPCJ006, Lot Number 24ADC130 ; SAMPCJ007, Lot Number 24ADC129; SAMPCJ008, Lot Number 24ADC128 ; SAMPCJ009, Lot Number 24ADC127 ; SAMPCJ010, Lot Number 24ADC126 ; SAMPCJ011, Lot Number 24ADC125
• 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: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that 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 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
• Distribution: Worldwide distribution.
• 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