BD Alaris PCEA Administration Set Recalled for Potential Leakage
BD Switzerland is recalling 110,350 units of Alaris PCEA Administration Sets due to a potential leak at the luer connection that may cause 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. The hazard involves a risk of harm (inadequate pain control due to under-infusion) in a medical device, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the criteria for a High severity score.
Plain-English summary
BD Switzerland SARL is recalling 110,350 units of BD Alaris PCEA Administration Sets, Catalog Number 10800177. The affected products are Microbore Tubing with Yellow Identification Stripe and Anti-siphon Valve, identified by UDI 10885403234422 and Lot Numbers 19016200 and 19045273. These sets are intended for patient-controlled analgesia (PCA) and cannot be used for gravity infusion.
The recall was initiated because 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 the set or during use. The most likely health consequence associated with this leak is inadequate pain control for the patient due to an under-infusion of medication.
The products were distributed worldwide, including nationwide in the United States, as well as in Canada and Belgium. Healthcare facilities and users should stop using the affected lots and contact BD Switzerland SARL for further instructions or replacement.
The recalled product
- Product
- BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - 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
- Hazard
- 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 (2)
- UDI: 10885403234422
- Lot Numbers: 19016200 19045273
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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