—#43539

Product

Paradigm Link -- Blood Glucose Monitor.

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K041478
Affected lot / code info: All lots under the following Catalog Numbers: 322200; 322201; 322202; 322203; 322204; 322205; 322206; 322207.

Why it was recalled

BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

Root cause (FDA determination)

Other

Action the firm took

Recall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2006-01-05
Posted by FDA: 2006-02-25
Terminated: 2006-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43539. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.