# FDA recall Z-1968-2020

> **BD SWITZERLAND SARL** · Class II · device recall initiated 2020-04-09.

## 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.

## Distribution

Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.

## Key facts

- **Recall number:** Z-1968-2020
- **Recalling firm:** BD SWITZERLAND SARL
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-09
- **Report date:** 2020-05-20
- **Termination date:** 2020-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eysins, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1968-2020

## Citation

> AI Analytics. FDA recall Z-1968-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1968-2020. Source: US FDA. Licensed CC0.

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