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Recall Observatory FDA recall evidence

Device product

Non-Vented Dispensing Pin with 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)

Z-1907-2016

April 14, 2016

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 73986
Status
Terminated
Classification
Class II
Quantity
11,000 units available in commercial channels
Official record key
device-enforcement:Z-1907-2016

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.