Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number
Summary
The FDA issued a Class II for Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.
Details
Source
Device Recall
External ID
Z-2757-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
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
Lot/Code Info: 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
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
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2757-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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