| Class 2 Device Recall Virotek SAFELET 2.0 mm Safety Lancets | |
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
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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
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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 |
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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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