Recall Z-1969-2020— BD SWITZERLAND SARL

Name: FDA recall Z-1969-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-09

Class II · Terminated

Class II FDA medical device recall by BD SWITZERLAND SARL, initiated 2020-04-09, terminated 2020-11-02. It names one FDA 510(k) clearance: K811885. 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..

Recalling firm: BD SWITZERLAND SARL
Classification: Class II
Status: Terminated
Initiated: 2020-04-09
Terminated: 2020-11-02
Firm location: Eysins, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K811885 — 30-30-2 700 SYRINGE EXTENSION SETY·cleared 1981-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.