JANUARY 5 - JANUARY 5, 2011 RECALLS AND FIELD CORRECTIONS:...

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JANUARY 5, 2011 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I ___________________________________ PRODUCT Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601. ..STERILE. ..FRESENIUS KABI. ..Made in the Netherlands". Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber. Recall # Z-0616-2011 CODE Lot numbers: WKT252, YLT061, ZCT011 and ZGT052 RECALLING FIRM/MANUFACTURER Recalling Firm: Fresenius Kabi, LLC, Redmond, WA, by letter dated October 18, 2010 by telephone on October 22, 2010. Manufacturer: Fresenius Hemocare Netherlands B.V, Emmer-Compascuum, Netherlands. Firm initiated recall is ongoing. REASON Potential for patient hematocrit dropped to levels lower than expected post-treatment. VOLUME OF PRODUCT IN COMMERCE 255 units DISTRIBUTION AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX. RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ___________________________________ PRODUCT XELERIS (1.0, 1.1, 2.0 & 2.1) Processing and Review Workstation The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration. Recall # Recall # Z-0537-2011 CODE SN 0000CZC5481313 0000FRB43605FW 0000FRB31602VG 0000FRB31602XV 0000FRB31602TX 000000205262-1 000000205262-2 000000205262-8 00000041E0CFDB 00000033512139 0000000CGMK00J 0000000HBLL50J 00000001P19K0J 00000006GD9K0J 0000FRB31602VS 0000FRB32509B2 00000000040129 0000FRB40906XP 0000FRB4330B3P 0000FRB43605GQ 0000FR31125601 000000099YGCCT 0000FRB4380JXX 0000CZC530038W 000000286147BC 000CZC5484130S 000000696468C0 0000001136348F 000000108796-9 0000000BA60A9F 000000109266-4 00000108976-17 00000108976-48 00000108976-45 00000108976-49 00000109471-23 000000109471-1 000000109460-2 00000CZC8273BM 0000CZC8225781 000000109541-4 000000109935-6 0000FRB40907L0 0000000HYZN70J 00000003T31BOJ 00000003T31B0J 00000003T31BOJ 00000000203325 000000099YGCHW 000000099YGCGK 000000204258-5 0000CZC5230HF2 0000FRB4370B25 000000099HXVXT 0000CZC5341NB2 0000CZC5341NGL
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0000CZC5341NLC 00000000207741 000000107859-5 0000FRB4370DGK 00000108968-28 00000050C5965C 00000016BBDA0E 00000109032 18 000000109077-2 00000000210085 000000109408-8 00000109408-19 000000417E8E0E 000000109261-6 000000109624-3 00000046877888 000000109535-4 000000109767-2 00000000005349 00000005597D9P 0000040770-241 0000040770-464 0000FRB32509CJ 0000000GGDCK0J 0000FRB3260GY7 0000FRB3270GH9 0000FRB3250560 0000PA44275203 0000FRB43402X2 00000007GDCK0J 0000FRB3250560 0000FRB3260B7D 0000FRB44109WZ 0000FRB325055R 0000FRB4330B5G 0000PA47015153 0000FRB3270GVR 0000FRB4330B9Z 0000KY33131392 0000FRB4400J0H 0000FRB4330B9K 0000FRB4380C0Q 00000001H2680J 0000000CL2680J 00000000101577 0000000J2LX60J 00000000205819 0000FRB44103KW 0000FRB43708SK 0000FRB4370DGT 0000FRB43708T1 0000FRB43704BL 0000FRB44103KQ 0000FRB44103KC 0000FRB40907J8 0000FRB3270C7W 000000107155-3 0000FRB3260C7H 0000CZC5230HCB 0000CZC5230HCV 0000CZC535012J 0000CZC5310XPX 0000CZC5341NNH 0000CZC5230HCP 0000CZC5341NXM 0000CZC5341NBS 0000003B231900 00000003BB11D0 0000007EDFACA5 00000053972594 0000CZC5341NB6 0000CZC5471CDK 000000108394-5 0000005EAA7B9E 0000004B0DB157 000000738E8044 000000209093-4 0000000AE4672B 00000000108865 0000000328D6BB 00000061F96DE3 000000671D1A93 00000000109515 00000067746E13 0000007B642D27 000000211114-2 000000109283 4 00000109283 13 0000005EE43FCD 0000003FF209C4 000000109754-8 000000268094EE 0000002452179E 000000110137-5 00000000110172 0000006B5FE154 0000CZC91280CY 00000000005110 0000000FCF9K0J 0000000FW1F70J 0000000DQF9K0J 00000008ZZN70J 0000000C23DFOJ 00000002HDCK0J 0000FRB3150L6Q 0000000GSHBK0J 00000005597D6C 000000000-4-15 0000000GCGCKOJ 0000FRB3260B0W 0000FRB32408FY 0000FRB3160120 0000FRB3270GGW 0000040770- 078 0000FRB3260GZM 0000FRB3260GY0 0000FRB316013D 0000FRB3280B87 0000FRB316011Z 0000FRB325096K 00000005597F7F 0000FRB3107760 000000099ALYMH 0000FRB32507GV 0000FRB3270GGV 0000FR31125590 000000099YGCFM 0000FRB40907KG 0000FRB32609ZH 000FRB43300BBF 0000FRB3270GVC 000000099YGCGW 000000099YGCKN 0000FRB3250C9L 0000106662-0-0 000000099YGCLH 0000FRB4330B3X 0000FRB44109WW 000000099YGCLK 000000000002HG 0000FRB3280C9S 0000FRB43402W7 0000000FSTKH0J 0000FRB3280C9H 000000204152-2 0000FRB42508X0 0000FRB41308VX 00000000008216 0000FRB3270GVH 000000099YGCCV 0000FRB43605GJ 0000FRB44106F3 0000FRB43605HZ 0000FRB42508QJ 0000FRB43302WX 000000099HXVXA 000FRB437006CF 000000099HXVYH 0000FRB43704B8 0000FRB4090L01 000000099YGCDR 0000FRB43402VR 00000000204706 0000FRB42508W9 0000FRB42508VP 0000FRB4270JC6 0000FRB44106DZ 0000FRB4370CYV 0000FRB4270JL1 0000FRB4370DBY 0000CZC5300347 0000CZC530035H 0000CZC5341P0V 0000CZC5361JXF 0000CZC5341NS9 0000CZC535012Z 000000206690-0 0000CZC5341NPM 000000099YGCDY 0000000L306R75 00000000057340 0000CZC5341NXZ 00000000057329 0000CZC530036X 0000CZC530036W
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0000FRB3280B90 000000207802-1 000000207802-5 0000CZC5341NHZ 00000000107912
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This note was uploaded on 07/10/2011 for the course ECON 101 taught by Professor Tuner during the Spring '11 term at Solano Community College.

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JANUARY 5 - JANUARY 5, 2011 RECALLS AND FIELD CORRECTIONS:...

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