Z-0763-04
BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test...
Becton Dickinson & Co / initiated 2004-01-29 / Terminated
Becton Dickinson & Company began a recall of 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... on . The reason FDA records is "39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0763-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Becton Dickinson & Co
- 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.
- Product code
- NBW System, Test, Blood Glucose, Over The Counter
- 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 root cause
- 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.
- Product codes and lots
- 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.
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
