Becton Dickinson Recalls CareFusion MaxPlus Clear Needleless Connectors
Becton Dickinson is recalling 115,200 CareFusion MaxPlus Clear Needleless Connectors because the valve may fail to close, posing risks of blood loss and air embolism.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that poses a risk of serious injury, specifically air embolism and blood loss, particularly in neonates.
Plain-English summary
Becton Dickinson & Company is recalling 115,200 units of the CareFusion MaxPlus Clear Needleless Connector, Catalog Number MP1000-C. The device is intended for positive displacement needleless access to IV lines and catheters during IV therapy. The affected units are identified by Lot Number 18085990 and have an expiration date of August 15, 2023. The recall covers distribution in the United States and Canada.
The recall was initiated because the connector valve may remain recessed and fail to fully close after a luer is disconnected. This defect can occur either temporarily or permanently. If the valve remains permanently open and goes undetected, there is a risk of blood loss and air embolism. The source text notes that this risk is especially significant in the neonate population.
Healthcare facilities and consumers should stop using the affected devices immediately. Users should check their inventory for the specific lot number and expiration date listed above. Becton Dickinson & Company is the recalling firm responsible for this action.
The recalled product
- Product
- CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — IV Therapy
- Hazard
- Affected units
- 115,200
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 (2)
- Lot Number: 18085990
- Exp. Date: 15-Aug-2023 UDI: 10885403223228
Distribution
Distributed nationwide across the United States.
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