Z-0904-05

Virotek SAFELET 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister...

Name: Z-0904-05 Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister...
Creator: Efoora, Inc. dba Virotek, L.L.C.
Published: 2005-05-05
License: https://open.fda.gov/license/

Efoora, Inc. dba Virotek, L.L.C. / initiated 2005-05-05 / Terminated / root cause: packaging

FDA source

Efoora, Inc. dba Virotek, L.L.C. began a recall of Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or 200 per box, 6 boxes per carton... on 2005-05-05. The reason FDA records is "The sterility of the lancets may be compromised due to inadequate packaging seals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0904-05
Status: Terminated
Initiated: 2005-05-05
Posted: 2005-06-17
Terminated: 2008-09-02
Recalling firm: Efoora, Inc. dba Virotek, L.L.C.
Product: Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or 200 per box, 6 boxes per carton; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Reason for recall: The sterility of the lancets may be compromised due to inadequate packaging seals.
Root cause tag: packaging
FDA 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 in commerce: 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 Kingdom and Zimbabwe.
Product codes and lots: stock code 5000052, lot numbers 0013, 0014, 0015, 0016, 0017, 0019, 0021

Product code FMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)