Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or
FDA device recall Z-0904-05 · posted 2005-06-17 · Terminated
Recall details
- Recalling firm
- Efoora, Inc. dba Virotek, L.L.C.
- Reason for recall
- The sterility of the lancets may be compromised due to inadequate packaging seals.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMK
- Quantity affected
- 250,150 units
- Distribution
- Nationwide and internationally to Australia, Belgium, Bolivia, Colombia, Finland, Israel, Italy, Japan, Mexico, Nigeria, Russia, Singapore, South Africa, Spain, Sweden, Taiwan, Trinidad, United Kingdo
- Date initiated
- 2005-05-05
- Date posted
- 2005-06-17
- Date terminated
- 2008-09-02
- Location
- Buffalo Grove, IL
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