B. Braun Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1906-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: April 14, 2016

Date Posted: June 8, 2016

Recall Number: Z-1906-2016

Event ID: 73986

Reason for Recall:

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.

Status: Terminated

Product Quantity: Approximately 11,000 units available in commercial channels

Code Information:

Serial Numbers: 61342856, 61181826, 61200666, 61221679, 61250908, 61230098, 61259709, 61316886, 61325854, 61318424, 61321589, 61315864, 61187901, 61282829, 61247686, 61266076, 61277092 Product Catalog Number: 412023 and 412027

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated