BD Alaris PCEA Administration Set — Class II medical device recall Z-1968-2020
Terminated recall by BD SWITZERLAND SARL, reported 2020-05-20, distributed nationwide. The products have the potential to leak between the connection of the male luer and the yellow striped tubing.
| Recall number | Z-1968-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD SWITZERLAND SARL, Eysins, N/A, Switzerland |
| Recall initiated | 2020-04-09 |
| Classified | 2020-05-13 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA |
| Quantity | 110,350 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10885403234422 |
| Lot numbers | 19016200, 19045273 |
| Model numbers | 10800177 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1968-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.