Medline Baby Care Kits Recalled Due to Syringe Quality Issues
Medline is recalling Baby Care Kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk to patient health due to syringe defects, but the source text does not report any specific illnesses, injuries, or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific lots of Baby Care Kits labeled as BABY CARE KIT UNIV (Pack Numbers DYKL1025 and DYKL1025H). These medical convenience kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.
The recall is being conducted because leaks, breakage, and other quality issues have been identified in the syringes. These defects may pose a risk to patient health. The affected products were distributed worldwide.
Healthcare providers and consumers should stop using the affected kits and contact Medline for further instructions or a return. Specific lot numbers are listed in the official recall documentation.
The recalled product
- Product
- Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- DYKL1025
- Lot Number 21JBA955
- Lot Number 21LBX335
- Lot Number 22BBW368
- Lot Number 22FBT155
- Lot Number 22IBA604
- Lot Number 22JBJ323
- Lot Number 23ABH574
- Lot Number 23ABS213
- Lot Number 23CBT397
- Lot Number 23FBI255
- Lot Number 23GBF800
- Lot Number 23IBN598
- DYKL1025H
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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