FDA Device recall Z-1969-2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usa…
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usa… by Bd Switzerland Sarl, citing 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 like….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1969-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-09 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bd Switzerland Sarl |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1969-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.