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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description HemoCue® Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Recall Number Z-0101-2014
Classification Class II
Code Info Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 & 1304737. Part Number 111717: Lot Numbers: 1208657, 1208661, 1208662, 1208665, 1209666, 1209668, 1209673, 1209676, 1210679, 1210680, 1210682, 1210684, 1210686, 1210689, 1211693, 1211695, 1211698, 1212700, 1212704, 1212707, 1301709, 1301713, 1301714, 1301716, 1301718, 1302720, 1302722, 1302724 & 1304738. Part Number 111722: Lot numbers: 1209672, 1210687, 1212701 & 1303727. Part Number 116101; Lot Numbers: 1303730 & 1303735.
Product Distributed Qty 42,330 packages/4 boxes/25 microcuvetes
Reason For Recall HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.

Event Detail

Event Id 65920
Product Type Devices
Status Ongoing
Recalling Firm HemoCue AB
City Angelholm
State
Country SE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.
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