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 syringe to female lue
Check against the official notice below — it lists the full affected range.
BD Switzerland SARL is recalling BD Alaris PCEA Administration Sets with microbore tubing featuring yellow identification stripe (catalog number 10800177). The recalled products have the potential to leak at the connection between the male luer and yellow striped tubing, and this leaking may occur during priming or while in use. The primary health risk associated with this leak is inadequate pain control for patients receiving medication through the set due to under-infusion. Approximately 110,350 units were distributed worldwide, including nationwide distribution in the US and distribution to Canada and Belgium. The affected lot numbers are 19016200 and 19045273.
The source document does not specify a remedy or any actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium. Quantity: 110,350 Lot/code info: UDI: 10885403234422; Lot Numbers: 19016200 19045273
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.