Becton Dickinson & Company recalls PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing…

Recall date

September 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0387-2019

FDA classification

Class II

Brand / firm

Becton Dickinson & Company

Sold / distributed

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 Ara…

Why it was recalled

The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 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.