FDAFDA · Food and drugs·Recall number Z-1906-2016
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)
Published June 8, 2016 · Recall initiated: April 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B. Braun Medical, Inc.
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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