Z-2757-2024 Class II Ongoing
FDA device recall Z-2757-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 8, 2024 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 4, 2024
- Initiation Date
- Apr 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number DYKB1011B; 3) BABY KIT, Pack Number DYKP1021; 4) BABY KIT MED CENTER, Pack Number DYKM2149; 5) BABY KIT MED CENTER, Pack Number DYKM2149A; 6) GIRAFFE BED KIT, Pack Number DYKL1839; 7) GIRAFFE BED KIT, Pack Number DYKL1839H; 8) NEWBORN SUPPLIES, Pack Number ACC010791; 9) NEWBORN SUPPLIES + POSTPARTUM, Pack Number ACC010597C; 10) NEWBORN KIT, Pack Number DYKL1803
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.
Distribution Pattern
Worldwide
Code Information
DYKB1011C, Lot Number 23ABQ306 ; DYKB1011C, Lot Number 23BBT085 ; DYKB1011C, Lot Number 23CBX152 ; DYKB1011C, Lot Number 23EBE383 ; DYKB1011C, Lot Number 23HBM160 ; DYKB1011C, Lot Number 23JBQ260 ; DYKB1011C, Lot Number 24BBM242 ; DYKB1011B, Lot Number 22DBB502 ; DYKB1011B, Lot Number 22FBS047 ; DYKB1011B, Lot Number 22HBO787 ; DYKB1011B, Lot Number 22KBB475 ; DYKP1021 , Lot Number 23FBK519 ; DYKP1021 , Lot Number 24ABO781 ; DYKP1021 , Lot Number 24ABW188 ; DYKP1021 , Lot Number 24ABX254 ; DYKM2149 , Lot Number 23ABU332 ; DYKM2149 , Lot Number 23BBL263 ; DYKM2149 , Lot Number 23HBF070 ; DYKM2149 , Lot Number 23JBE447 ; DYKM2149A, Lot Number 23LBJ716 ; DYKM2149A, Lot Number 24ABO812 ; DYKL1839 , Lot Number 22LBT106 ; DYKL1839 , Lot Number 23DBL613 ; DYKL1839 , Lot Number 23GBJ764 ; DYKL1839 , Lot Number 23JBK240 ; DYKL1839H, Lot Number 22LBT106 ; DYKL1839H, Lot Number 23DBL613 ; DYKL1839H, Lot Number 23GBJ764 ; DYKL1839H, Lot Number 23JBK240 ; ACC010791, Lot Number 24BDB871 ; ACC010597C , Lot Number 23HDB884 ; ACC010597C , Lot Number 23IDA286 ; ACC010597C , Lot Number 23JDA167 ; ACC010597C , Lot Number 23JDA499 ; ACC010597C , Lot Number 23JDA801 ; ACC010597C , Lot Number 23JDB763 ; ACC010597C , Lot Number 23JDB813 ; ACC010597C , Lot Number 23KDB477 ; DYKL1803 , Lot Number 21KBI050 ; DYKL1803 , Lot Number 22GBJ686 ; DYKL1803 , Lot Number 22HBN282 ; DYKL1803 , Lot Number 22IBP034 ; DYKL1803 , Lot Number 22JBH897 ; DYKL1803 , Lot Number 23BBN707 ; DYKL1803 , Lot Number 23CBR949 ; DYKL1803 , Lot Number 23FBJ793 ; DYKL1803 , Lot Number 23HBI726 ; DYKL1803 , Lot Number 23HBY914
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2757-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026