BD Alaris PCEA Administration Set Recalled for Potential Leaking
BD is recalling 110,350 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 is classified as FDA Class II, and the source text identifies a risk of harm (inadequate pain control) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BD Switzerland SARL is recalling 110,350 units of the BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07. The recall covers units distributed in the United States, Canada, and Belgium.
The recall is due to a potential leak between the male luer connection and the yellow striped tubing. This leak may be observed during priming or while the set is in use. The most likely health consequence of this leak is inadequate pain control for the patient due to an under-infusion of medication.
Healthcare facilities should stop using the affected lots and contact BD for further instructions. The affected lot numbers are: 18125862, 18125863, 18125864, 18125865, 18126360, 18126636, 18126637, 18126638, 18126639, 18126723, 19015637, 19015638, 19015639, 19015640, 19015798, 19015799, 19015949, 19017207, 19025135, 19025136, 19025228, 19025229, 19046125, and 19046126.
The recalled product
- Product
- BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
- Manufacturer
- BD SWITZERLAND SARL
- Category
- Medical Device — Infusion Set
- 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)
- UDI: 10885403460234
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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