Use cautionMedical device recall · FDA · Published April 9, 2020
BD Alaris PCEA Administration Set Leak Risk: Inadequate Pain Control
BD recalls Alaris PCEA Administration Sets with yellow tubing that may leak, causing under-infusion of medication and inadequate pain control. Affected units have specific catalog numbers and lot ranges.
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.
Take action
Contact the company
📍Recalling firmBD SWITZERLAND SARLTerre Bonne Park A4, Route De Crassier 17 · Eysins, Switzerland
“BD Alaris PCEA Administration Set Leak Risk: Inadequate Pain Control.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65453-bd-alaris-pcea-administration-set-leak-risk-inadequate-pain-control. Based on FDA recall #Z-1967-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1967-2020%22&limit=1).
The FDA announced on April 9, 2020, that BD SWITZERLAND SARL is recalling the BD Alaris PCEA Administration Set with Microbore Tubing due to a potential leak between the male luer and yellow striped tubing. This defect may result in inadequate pain control for patients due to under-infusion of medication.
How to tell if you have it
Brand: BD
Product: BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV
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.
Context
GovInfoNow's records show BD SWITZERLAND SARL has 8 other recalls on record since April 18, 2024. Recent recalls include the BD Alaris Pump Infusion Sets Recall dated August 19, 2026, and the BD 60-In Extension Sets recall dated June 16, 2026. Other recent recalls of similar products include the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), the Medline IV Sets recall (December 31, 2025), and the Abiomed Impella CP Set Recall (June 11, 2026).
How to tell if you have this one
Check for the yellow identification stripe on the tubing. Affected units have catalog number 30893-07 and specific lot numbers listed in the recall notice.
Brand
BD
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
Recall number
Product, codes & lots
Z-1967-2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - 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.; UDI: 10885403460234; Lot Numbers: 18125862 18125863 18125864 18125865 18126360 18126636 18126637 18126638 18126639 18126723 19015637 19015638 19015639 19015640 19015798 19015799 19015949 19017207 19025135 19025136 19025228 19025229 19046125 19046126
Z-1968-2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - 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.; UDI: 10885403234422; Lot Numbers: 19016200 19045273
Z-1969-2020
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.; Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483
Based on the official FDA remedy
What to do — step by step
Check for Leaks
Inspect the tubing for leaks between the male luer connector and the yellow-striped tubing during priming or use.
Replace Set
Replace the administration set with a new one that has no yellow identification stripe on the tubing.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1967-2020 (April 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1967-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.