Medical Device
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Efoora, Inc. dba Virotek, L.L.C.

Buffalo Grove, IL

Efoora, Inc. dba Virotek, L.L.C. appears in FDA device records in Buffalo Grove, IL. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

No FDA product codes recorded against this company.

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0905-05Virotek 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 60089The sterility of the lancets may be compromised due to inadequate packaging seals.Terminated
Z-0904-05Virotek 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 60089The sterility of the lancets may be compromised due to inadequate packaging seals.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain