Medline Recalls Central Line Kits Due to Incorrect Age Labeling
Medline Industries is recalling Central Line kits due to a printing error that mislabels the intended patient age. The error could lead to use on the wrong patient population.
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 the defect could lead to use on the wrong patient population, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries Inc is recalling the Central Line >34 Weeks Kit (Unit No: DYNDC1987A) due to a labeling defect. The recall affects 320 units from lot 14DB9277 and 320 units from lot 14PB2878, which were distributed in the United States, including Pennsylvania.
The print plate artwork for the affected lots incorrectly displays "Central Line <34 Weeks Kit" instead of the correct "Central Line >34 Weeks Kit." This error involves an incorrect sign in front of the number 34. The device is intended for patients greater than 34 weeks of age.
The defect may lead to the product being used on a patient population younger than 34 weeks, rather than the intended population older than 34 weeks. No specific instructions for consumers are provided in the source text, but the recall is driven by the risk of using the device on the wrong age group.
The recalled product
- Product
- Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, n
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Catheters
- Hazard
Distribution
Distributed in 1 state:
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