B. Braun Medical, Inc. recalls Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medica…

Recall date

April 14, 2016

Source

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

Recall number

Z-1906-2016

FDA classification

Class II

Brand / firm

B. Braun Medical, Inc.

Sold / distributed

US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico

Why it was recalled

BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.

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

What was recalled

Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)