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U.S. Department of Health and Human Services

Class 2 Device Recall Virotek SAFELET 2.0 mm Safety Lancets

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  Class 2 Device Recall Virotek SAFELET 2.0 mm Safety Lancets see related information
Date Initiated by Firm May 05, 2005
Date Posted June 17, 2005
Recall Status1 Terminated 3 on September 02, 2008
Recall Number Z-0905-05
Recall Event ID 31966
Product Classification Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature - Product Code FMK
Product 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
Code Information stock code 5000052, 5000101and 5000115, lot numbers 0018, 0023, 0024, 0025, 0026, 0027, 0028 
Recalling Firm/
Manufacturer		 Efoora, Inc. dba Virotek, L.L.C.
900 Asbury Dr
Buffalo Grove IL 60089-4557
For Additional Information Contact Ms. Mary Hill
847-634-4500 Ext. 277
Manufacturer Reason
for Recall		 The sterility of the lancets may be compromised due to inadequate packaging seals.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 763,500 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 Kingdom and Zimbabwe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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