Recall archive / FDA device enforcement
Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 1... — FDA record Z-3033-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3033-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Apr 8, 2024
- Center classification date
- Sep 6, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.