Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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.