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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
Recall Number Z-1182-2014
Classification Class II
Code Info 2459798 2472512 2472513 2476329 2480613 2480614 2489880 2493968 2498070 2503427 2506816 2511212 2513711 2521591 2521592 2525786 2529541 2533323 2547290 2547291 2551266 2555870 2560932 2569056 2569057 2569058 2463882 2467732 2574219
Product Distributed Qty
Reason For Recall issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes

Event Detail

Event Id 66837
Product Type Devices
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Keene
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
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