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Recall Observatory FDA recall evidence

Device 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

Z-3033-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94583
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-3033-2024

Official wording

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.

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

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.