RecallRadar

FDA Device recall Z-2757-2024

Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C

On 2024-09-04 the FDA classified a Class II recall of Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C by Medline Industries Northfield, citing 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 m….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2757-2024
ClassificationClass II
Statusongoing
Initiated2024-04-08
Published2024-09-04
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
Distributionn/a

Product

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

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.

Identifiers

code_info
DYKB1011C, Lot Number 23ABQ306 ; DYKB1011C, Lot Number 23BBT085 ; DYKB1011C, Lot Number 23CBX152 ; DYKB1011C, Lot Nu…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2757-2024%22

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