Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200

FDA Recall Z-1165-2007 · Posted 2007-08-16

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeFMK
Date Initiated2007-03-30
Date Terminated2007-12-03
Product Quantity632 cartons (200 units per carton)

Reason for Recall

Lancet tip may not fully retract and cause needle stick and exposure to used lancets.

Firm Action

The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users. The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Product was distributed nationwide to distributors and wholesale dealers.

Official Source

View FDA Recall →

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

↑