FDA Device Recall Z-0004-2009: Lifescan Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-2009.

Recall Res Number

Z-0004-2009

Recalling Firm / Manufacturer

Lifescan Inc

FEI Number

2939301

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-09-19

Date Posted

2008-11-21

Date Terminated

2010-12-27

Product Code

NBW

Event Number

49413

Product Quantity

35308 vials

Product Description One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.

Reason for Recall Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.

Action Details Urgent: Medical Device Recall letters, dated 09/19/2008, were sent to consumer end users, direct account distributors and wholesalers, health care providers, and pharmacists notifying them of the recall. The letter states that if customers have strips from Lot 2829235, they should call LifeScan at 1-866-247-1281 and tell customer service that they have strips that need to be replaced. Customer service and QA scripts were provided to LifeScan staff to provide to any callers who inquire about the recall. The distributors and wholesalers were to locate and sequester any inventory from the affected Lot 2829235; request all recalled inventory from customers; call Carolina Logistics for an RGA; and when only the affected returned product is received, a credit will be issued.

Distribution Pattern Nationwide Distribution --- including Puerto Rico.

Code Information / Serial Numbers Lot number 2829235

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Medical Device Recall: Z-0004-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer