BD SWITZERLAND SARL: Medical Device Recall in 2020 - (Recall #: Z-1969-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 9, 2020

Date Posted: May 20, 2020

Recall Number: Z-1969-2020

Event ID: 85525

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.

Status: Terminated

Product Quantity: 110,350

Code Information:

Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483

Distribution Pattern:

Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.

Voluntary or Mandated:

Voluntary: Firm initiated