Becton Dickinson & Co. recalls BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath¿ Pres…

Recall date

February 12, 2016

Source

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

Recall number

Z-0877-2017

FDA classification

Class II

Brand / firm

Becton Dickinson & Co.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, W…

Why it was recalled

BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.

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

What was recalled

BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.