Recall Z-0905-05 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Efoora, Inc. dba Virotek, L.L.C.
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
| Date | Jun 17, 2005 (initiated May 5, 2005) |
| Status | Terminated |
| Reason | The sterility of the lancets may be compromised due to inadequate packaging seals. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.