Medline procedural kits recalled due to syringe quality issues
Medline is recalling specific procedural kits because they contain plastic syringes affected by an FDA Safety Alert regarding 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential patient health risks without confirmed adverse events.
Plain-English summary
Medline Industries, LP is recalling specific procedural kits, including Baby Admit, Baby Kit, Giraffe Bed Kit, and Newborn Supplies kits. The recall is necessary because these kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.
The FDA Safety Alert identified leaks, breakage, and other quality issues in the syringes. These defects may pose a risk to patient health. The affected products were distributed worldwide.
Healthcare facilities and consumers should check their inventory for the specific pack numbers and lot numbers listed in the recall notice. If you have these products, stop using them and contact Medline Industries for instructions on how to return or dispose of the items.
The recalled product
- 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
- 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 (20)
- DYKB1011C
- Lot Number 23ABQ306
- Lot Number 23BBT085
- Lot Number 23CBX152
- Lot Number 23EBE383
- Lot Number 23HBM160
- Lot Number 23JBQ260
- Lot Number 24BBM242
- DYKB1011B
- Lot Number 22DBB502
- Lot Number 22FBS047
- Lot Number 22HBO787
- Lot Number 22KBB475
- DYKP1021
- Lot Number 23FBK519
- Lot Number 24ABO781
- Lot Number 24ABW188
- Lot Number 24ABX254
- DYKM2149
- Lot Number 23ABU332
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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