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Terminated

Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089

FDA Recall Z-0905-05 · Posted 2005-06-17

Recalling FirmEfoora, Inc. dba Virotek, L.L.C.
Recall StatusTerminated
Product CodeFMK
Date Initiated2005-05-05
Date Terminated2008-09-02
Product Quantity763,500 units

Reason for Recall

The sterility of the lancets may be compromised due to inadequate packaging seals.

Firm Action

Efoora/Virotek sent recall notifications to their customers via fax and DHL delivery on 5/5/05 through 5/27/05. The accounts were informed that the sterility of the lancets had been compromised due to inadequate seals. The accounts were requested to check their inventories for the affected lots, discontinue their use/distribution, and return the product to Efoora for a refund. Any questions were directed to Mary Hill, Director of Quality Assurance at 847-634-4500, ext. 277.

Root Cause

Other

Distribution Pattern

Nationwide and internationally to Australia, Belgium, Bolivia, Colombia, Finland, Israel, Italy, Japan, Mexico, Nigeria, Russia, Singapore, South Africa, Spain, Sweden, Taiwan, Trinidad, United Kingdom and Zimbabwe.

Official Source

View FDA Recall →

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

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