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 syringe to female lue
Check against the official notice below — it lists the full affected range.
BD Switzerland SARL has recalled the BD Alaris PCEA Administration Set with Microbore Tubing with Yellow Identification Stripe (Catalog Number 30893-07) due to a potential leak between the connection of the male luer and the yellow striped tubing. This leak may appear while priming the set or during use and could result in inadequate pain control for patients due to under-infusion of medication. The recall affects 110,350 units distributed nationwide in the United States and in Canada and Belgium.
The affected products are identified by UDI 10885403460234 and the following lot numbers: 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 source document does not specify a remedy or recommended action for consumers.
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: 10885403460234; Lot Numbers: 18125862 18125863 18125864 18125865 18126360 18126636 18126637 18126638 18126639 18126723 19015637 19015638 19015639 19015640 19015798 19015799 19015949 19017207 19025135 19025136 19025228 19025229 19046125 19046126
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.