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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 29, 2004
Recall Number Z-0763-04
Recall Event ID 28391
510(K)Number K022580  K022581  K030531  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product BD Test Strips.

The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips).

Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.
Code Information US Market Lot Numbers: 2064322; 2064333; 2071311; 2078294; 2099353; 2120336; 3057009; 3064013; 3064016; 3064018; 3064030; 3064037; 3064069; 3064076; 3064079; 3064083; 3064090; 3064104; 3064107; 3064112; 3064118; 3064121; 3064125; 3064132; 3064156; 3064167; 3064170; 3064174; 3064182; 3064188; 3064237; 3064245; 3064279; 3071009; 3071153; 3078041; 3078128; 3092028; 3106007.  Canadian Market Lot Numbers: 3064125; 3071153; 3064279; 3071009; 3071153; 3064156; 3064182; 3064188.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Blair Harvey
201-847-6324
Manufacturer Reason
for Recall		 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
FDA Determined
Cause 2		 Other
Action Trade and health care professionals were sent recalled letters dated 1/29/2004.
Quantity in Commerce 15011221
Distribution The product was shipped nationwide to 28 Wholesalers, 15 retail pharmacies and pharmacy chains, 18 managed markets/Mail order facilities, and 616 health care professionals. There are 29 Canadian consignees.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = BECTON DICKINSON & CO.
510(K)s with Product Code = NBW and Original Applicant = MINIMED, INC.
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