All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction. Part Number: Description: 020-524-01, System,OUS,US; 020-524-01F, System,OUS,US; 020-524-01Y, UltraSmart Meter; 020-524-02, System,OUS,EAS-C,US; 020-524-03, System,OUS,EAS-S,US; 020-524-04F, OT UltraSmart System Kit V. 4 USA; 020-524-04Y, UltraSmart System; 020-524-05, UltraSmart System -EAS-C; 020-524-06, UltraSmart System -EAS-S; 020-524-10, OT UltraSmart System Kit; 020-524-10F, OT UltraSmart System Kit; OT UltraSmart System Kit V. 10 USA; 020-524-10Y, OT UltraSmart System Kit; 020-524-11, System, EAS-C, OUS, US; 020-524-12, System, EAS-S, OUS, US; 020-524-13, OT UltraSmart System; 020-759-02F, OT UltraSmart Meter V.2 USA; 020-759-03F, OT UltraSmart Meter V.3 USA; 020-761-01F, Starter,OUS,US; 020-761-02, OT UltraSmart Starter; 020-761-02F, OT UltraSmart Starter; 020-761-04, OT UltraSmart Starter; 020-761-04F OT UltraSmart Starter; 020-761-05 OT UltraSmart Starter Kit; 020-761-05F, OT UltraSmart Starter Kit; 020-926-01, Dist Kit,SM,OTU,US; 020-930-01, Dist,Kit,OTU/OUS,US; 020-971-01, Disp,Counter,Ultra Kits; 021-075-01, UltraSmart SVP; 021-113-01, Display, Hanging, OUT/OUS, US; 021-133-01, Display, Counter, OTU/OUS Kits; 021-135-01, Span Display, Hanging, OTU, US; and 021-166-01, Display, Hanging, OTU/OUS Kits.
Product was released for distribution to 40,763 consignees worldwide. The firm provided the following distribution information: 124 wholesaler dealers, 224 distributors, 140 retailers and 40,275 consumers/users involved in the recall. The recall product was distributed in all States within the U.S. In addition, OneTouch UltraSmart meter kits with the affected UltraSmart Owner''s Booklets (AW 060-788-01A) have been distributed internationally in Canada, France, Germany, Italy, United Kingdom, Benelux, Sweden, Finland, Norway, Denmark, Spain, Portugal, Switzerland and Austria. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, and patients who received the recalled products.
제품 설명
LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; || All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction.
The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner''s Booklets between March 31, 2003 and October 3, 2003.
제품 설명
LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; || Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
OneTouch Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled with the incorrect Control Solution range. This lot was distributed outside of the US, exclusively in Italy.]
Product was released for distribution to 30 consignees nationwide. The firm provided the following distribution information: 6 wholesaler dealers, 20 distributors, 3 retailers and one (1) consumers/users involved in the recall. Note: This customer received a shipment of 2 Test Strip boxes (2 boxes x 50 strips/box = 100 test strips) as 'free goods' and was most likely for an LifeScan employee in the field. The lot was released from LifeScan's facility in Puerto Rico on May 1, 2003 and received at LifeScan's warehouse in Milpitas, CA on May 16, 2003. From the Milpitas warehouse, this lot was transferred to LifeScan's warehouse in Mechanicsburg, PA where it was received on June 16, 2003. The affected lot was distributed out of the Mechanicsburg, PA warehouse only. The recall product was distributed in the U.S. only, to the following states: AL, DE, FL, IL, IN, MA, MI, MN, MO, NC, NH, NJ, OH, PA, TN, TX, VA and WV. (A second lot was also mislabeled with the incorrect Control Solution range. This lot was manufactured outside of the US and distributed exclusively in Italy.) The total number of government sales/distribution centers that received the recall product = 0.
제품 설명
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., || 1000 Gibraltar Drive, Milpitas, CA 95037
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.
제품 설명
LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. || Testing of Blood Glucose Levels.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.
제품 설명
LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. || Testing of Blood Glucose Levels.