LATITUDE

Catalog # 322002 (fifty count packaging) Lot Number: 2064256.  Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256, 2064273, 2071280.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Product was distributed to the Becton Dickinson Canada, Inc.,

BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.

US Market BD Logic Lot Numbers: 2057320; 2057325; 2507327; 2057361; 2064338; 2064339; 2064341; 2071322; 2071351; 2078324; 2078326; 2078351; 2085324; 2085339; 2085351; 2085360; 2092322; 2092341; 2099322; 2099360; 2106325; 2113325; 3057022; 3057136; 3057147; 3064143; 3064147; 3064148; 3071015; 3071122; 3071125; 3071127; 3071170; 3078023; 3078037; 3078126; 3078135; 3078136; 3078141; 3078142; 3078174; 3085127; 3085139; 3085142; 3085149; 3085161; 3085174; 3092021; 3092122; 3092147; 3092174; 3092176; 3092177; 3099020; 3099147; 3099153; 3099171; 3099174; 3099176; 3099178; 3106147; 3106162; 3113141; 3120176; 3127176.  US Market BD Latitude Lot Numbers: 2057360; 2064360; 2071352; 2078352; 2078353; 2085353; 2092354; 2092360; 2099354; 2099357; 2106357; 2113357; 3057020; 3057021; 3057052; 3064021; 3064055; 3064056; 3064064; 3071021; 3071064; 3085090; 3092106; 3106022.  US Market Paradigm Link Blood Glucose Monitors Lot Numbers (co-Branded BD Logic): 3057049; 3057051; 3057055; 3057056; 3057058; 3057063; 3057064; 3057070; 3057071; 3057073; 3057098; 3057115; 3057120; 3064045; 3064058; 3064059; 3064077; 3064091; 3064097; 3071049; 3071056; 3071072; 3071076; 3071078; 3071080; 3071090; 3071104; 3071112; 3071120; 3078044; 3078045; 3078051; 3078064; 3078069; 3078077; 3078090; 3078101; 3078106; 3085055; 3085056; 3085079; 3085092; 3085093; 3085105; 3085106; 3085108; 3092044; 3092069; 3092085; 3092101; 3092104; 3099055; 3099083; 3099101; 3099108; 3099125; 3106072; 3106078; 3106097; 3106100; 3106118; 3113042; 3113069; 3113107; 3120104; 3127055; 3127056; 3127059; 3127076; 3134090; 3134107; 3141069; 3141112; 3155100.  US Market Paradigm Link (clear) Lot Numbers: 3057199; 3064189; 3064246; 3071178; 3085198; 3085281; 3085282; 3092188; 3120177.  US Market Paradigm Link (smoke) Lot Numbers: 3057183; 3057184; 3057197; 3057198; 3057227; 3057241; 3064204; 3064255; 3064267; 3071196; 3071199; 3071203; 3071245; 3071255; 3078202; 3085184; 3085287; 3092287.  US Market Paradigm Link (Blue) Lot Numbers: 3057189; 3057195; 3057233; 3064196; 3064197; 3064262; 3071232; 3071289; 3078196; 3078294; 3085181; 3085188; 3085261; 3085293; 3113178; 3113182.  US Market Paradigm Link (purple) Lot Numbers: 3057188; 3057196; 3057280; 3064192; 3064195; 3071205; 3071279; 3078184; 3078204; 3078232.  Canadian BD Latitude Lot Numbers: 3057041; 3057042; 3057043.  Canadian BD Logic Lot Numbers: 3057203; 3057205; 3057224; 3057234; 3064199; 3064203; 3064205; 3064224; 3071202; 3071204; 3071237; 3078198; 3078199; 3078205; 3085202; 3099204; 3120198.

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. || US Market BD Blood Glucose Monitoring System kit catalog Numbers: || 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); || 322050 (BD Latitude Diabetes Management System); || 322051 (BD Logic Blood Glucose Monitor); || 32205175 ( BD Logic Blood Glucose Monitor); || 322200 (Paradigm Link Blood Glucose Monitor - clear); || 322201 ( Paradigm Link Blood Glucose Monitor - smoke); || 322202 (Paradigm Link Blood Glucose Monitor - blue); || 322203 (Paradigm Link Blood Glucose Monitor - purple). || Canadian market BD Blood Glucose Monitoring System kit catalog numbers: || 322000 (BD Latitude Diabetes Management System); || 322001 (BD Logic Blood Glucose Monitor).

All lots under the following Catalog numbers:  322050; 322000; 322015; 322067.

Clinical Chemistry and Clinical Toxicology Devices

2

No

The firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include locations in Canada and Germany. There is one VA account.

BD Latitude (DMS) -- Blood Glucose Monitor.

Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,

Cardiovascular Devices

3

Yes

Nationwide distribution --- including states of AR, MI, PA

Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.