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Terminated

LifeScan OneTouch SureSoft Lancing Device, single use lancing device.

FDA Recall Z-0271-06 · Posted 2005-12-08

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2005-10-11
Date Terminated2006-11-21
Product Quantity1123 boxes

Reason for Recall

In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.

Firm Action

On October 11, 2005, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Root Cause

Other

Distribution Pattern

Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the US and canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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