Device product
HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Z-0101-2014
Product summary
- Firm
- HemoCue AB
- Event
- Event 65920
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,330 packages/4 boxes/25 microcuvetes
- Official record key
device-enforcement:Z-0101-2014
Official wording
Reason: HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
Code information: 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.
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.
Derived failure modes
-
Unknown
HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.