BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalo...
FDA Device Recall #Z-1967-2020 — Class II — April 9, 2020
Recall Summary
| Recall Number | Z-1967-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 9, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | BD SWITZERLAND SARL |
| Location | Eysins, N/A |
| Product Type | Devices |
| Quantity | 110,350 |
Product Description
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.
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.
Distribution Pattern
Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
Lot / Code Information
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
Other Recalls from BD SWITZERLAND SARL
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2453-2025 | Class II | BD PhaSeal Injector Luer (N30C), REF: 515001 B... | Jun 16, 2025 |
| Z-1973-2025 | Class II | BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF... | May 12, 2025 |
| Z-1971-2025 | Class II | BD Texium Needle-Free Syringe: 3 mL, REF: MY800... | May 12, 2025 |
| Z-1974-2025 | Class II | BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF... | May 12, 2025 |
| Z-1970-2025 | Class II | Alaris Pump Infusion Set: SmartSite Bag Access... | May 12, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.