PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device. Model 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access Device Model 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access Devices
FDA Recall Z-0132-2011 · Posted 2010-10-22
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Reason for Recall
Firm Action
Root Cause
Package design/selection
Distribution Pattern
Worldwide Distribution: USA, including the states of AL, AR, AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD.MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, MN, NY, NC, ND, OH, OK OR, PA, RI, SC, SD,TN, TX UT, VA, WA, WV, and WI, and the countries of: Australia, Austria, Bahamas, Canada, Colombia, Denmark, England, Germany, Greece, Hong Kong, Italy, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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