FDAFDA · Food and drugs·Recall number Z-1967-2020
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 luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
Published May 20, 2020 · Recall initiated: April 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BD SWITZERLAND SARL
- Distributor
- Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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