Z-1969-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 9, 2020
- Termination Date
- November 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110,350
Product Description
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - 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.
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 Pattern
Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
Code Information
Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483