FDAFDA · Food and drugs·Recall number Z-2757-2024
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
Published September 4, 2024 · Recall initiated: April 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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