CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
BD Alaris PCEA Administration Set, Microbore Tubing recalled
BD Switzerland Sarl is recalling BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, distributed nationwide in the US. The recall was initiated on 9 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1969-2020
- FDA event ID
- 85525
- Recalling firm
- BD Switzerland Sarl, Eysins, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2020
- FDA classified
- 13 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Infusion Pumps
Timeline
| 9 Apr 2020 | Recall initiated by company | |
| 13 May 2020 | Classified by FDA | +34 days |
| 20 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483
Where was it sold?
Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85525This product is part of a recall event; the main page for the event is BD Alaris PCEA Administration Set, Microbore Tubing recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BD Alaris PCEA Administration Set, Microbore Tubing recalled | BD Switzerland Sarl | Packaging Defects | Nationwide | |
| CLASS II | BD Alaris PCEA Administration Set, Microbore Tubing recalled | BD Switzerland Sarl | Packaging Defects | Nationwide |
More recalls from BD Switzerland Sarl
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | Non-DEHP Minibore Extension Set RES ME2010 recalled | BD Switzerland Sarl | Sterility | 26 states |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |
| Device | CLASS II | BD Connecta" BD Luer-Lok" recalled by Bd Switzerland Sarl | BD Switzerland Sarl | Foreign Material | 39 states |
| Device | CLASS II | BD PhaSeal Injector Luer (N30C) recalled by Bd Switzerland Sarl | BD Switzerland Sarl | Packaging Defects | Nationwide |
Other Infusion Pumps recalls
All 549| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | CLASS II | Plum administration sets recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |