BD Alaris PCEA Administration Set Recalled for Potential Leaking
BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.
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 a risk of harm (inadequate pain control) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
BD Switzerland SARL is recalling BD Alaris PCEA Administration Sets, Catalog Number 30893-04. The recall involves 110,350 units distributed in the United States, Canada, and Belgium. The affected lot numbers are 19016079, 19036183, 19045426, and 19115483.
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
Healthcare facilities should stop using the affected products and contact BD for instructions on how to return them.
The recalled product
- Product
- BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1.
- Manufacturer
- BD SWITZERLAND SARL
- Category
- Medical Device — Infusion Sets
- Affected units
- 110,350
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 (1)
- Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by BD SWITZERLAND SARL 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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