FDAClass IISeptember 4, 2024

Medline procedural kits labeled as: 1) BABY CARE KIT recall

Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H

Why was Medline procedural kits labeled as: 1) BABY CARE KIT recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

DYKL1025 , Lot Number 21JBA955 ; DYKL1025 , Lot Number 21LBX335 ; DYKL1025 , Lot Number 22BBW368 ; DYKL1025 , Lot Number 22FBT155 ; DYKL1025 , Lot Number 22IBA604 ; DYKL1025 , Lot Number 22JBJ323 ; DYKL1025 , Lot Number 23ABH574 ; DYKL1025 , Lot Number 23ABS213 ; DYKL1025 , Lot Number 23CBT397 ; DYKL1025 , Lot Number 23FBI255 ; DYKL1025 , Lot Number 23GBF800 ; DYKL1025 , Lot Number 23IBN598 ; DYKL1025H, Lot Number 21JBA955 ; DYKL1025H, Lot Number 21LBX335 ; DYKL1025H, Lot Number 22BBW368 ; DYKL1025H, Lot Number 22FBT155 ; DYKL1025H, Lot Number 22IBA604 ; DYKL1025H, Lot Number 22JBJ323 ; DYKL1025H, Lot Number 23ABH574 ; DYKL1025H, Lot Number 23ABS213 ; DYKL1025H, Lot Number 23CBT397 ; DYKL1025H, Lot Number 23FBI255 ; DYKL1025H, Lot Number 23GBF800 ; DYKL1025H, Lot Number 23IBN598

Product
Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Distribution
Worldwide
Recall date
September 4, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls