Medline Umbilical Line Kits Recalled Due to Syringe Quality Issues
Medline is recalling Umbilical Line 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 involves a medical device with quality defects (leaks, breakage) that pose a risk to patient health, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling Umbilical Line Kits with Foam (Pack Number DYNDL1588A) that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The recall involves specific lots: 23ELA011, 23HLA426, 23JLA181, and 24ALA515. The product was distributed worldwide.
The recall was initiated because leaks, breakage, and other quality issues have been identified in the plastic syringes. These defects may pose a risk to patient health.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A
- 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 (5)
- DYNDL1588A
- Lot Number 23ELA011
- Lot Number 23HLA426
- Lot Number 23JLA181
- Lot Number 24ALA515
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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