PlainRecalls
FDA Devices Moderate Class II Ongoing

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 6

Reported: September 18, 2024 Initiated: April 8, 2024 #Z-3033-2024

Product Description

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

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.

Details

Distribution
Worldwide distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by MEDLINE INDUSTRIES, LP - Northfield.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3033-2024.

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