FDA Recall Terminated

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.

Recall: Z-0763-04 · Initiated January 29, 2004

Recall

Recall Number
Z-0763-04
Event Number
28391
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
NBW
Status
Terminated
Root Cause
Other
Initiated
January 29, 2004
Posted
July 20, 2004
Terminated
October 29, 2004
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

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.

Reason

39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

Action

Trade and health care professionals were sent recalled letters dated 1/29/2004.

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.

Quantity

15011221