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Class 2 Device Recall LifeScan |
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Date Initiated by Firm |
June 09, 2005 |
Date Posted |
July 13, 2005 |
Recall Status1 |
Terminated 3 on December 21, 2006 |
Recall Number |
Z-0980-05 |
Recall Event ID |
32360 |
510(K)Number |
K021819
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Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
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Product |
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.
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Code Information |
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. |
Recalling Firm/ Manufacturer |
Lifescan Inc 1000 Gibraltar Dr Milpitas CA 95035-6301
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For Additional Information Contact |
Mario Lowe 408-942-5906
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Manufacturer Reason for Recall |
Meter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, 'Do you need a snack?' for glucose values from 20 through 59 mg/dL.
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FDA Determined Cause 2 |
Other |
Action |
On 6/9/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action. |
Quantity in Commerce |
584,291 units |
Distribution |
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.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
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