# FDA recall Z-0386-2019

> **Becton Dickinson & Company** · Class II · device recall initiated 2018-09-26.

## Product

PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07    Product Usage:  PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve.   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 the 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 lock and the yellow striped tubing.

## Distribution

Worldwide Distribution - US Nationwide in the states of:  AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MT, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Guam.    The products were distributed to the following foreign countries: Canada, United Arab Emirates and Saudi Arabia.

## Key facts

- **Recall number:** Z-0386-2019
- **Recalling firm:** Becton Dickinson & Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-26
- **Report date:** 2018-11-14
- **Termination date:** 2020-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin Lakes, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0386-2019

## Citation

> AI Analytics. FDA recall Z-0386-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0386-2019. Source: US FDA. Licensed CC0.

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