Recall Z-0484-2015— CooperSurgical, Inc.

Name: FDA recall Z-0484-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-27

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2014-10-27, terminated 2015-05-29. It names one FDA 510(k) clearance: K905747. Product: CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.. Reason: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-27
Terminated: 2015-05-29
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K905747 — LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSORCoopervision Surgical·cleared 1991-09-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

Reason for recall

Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode

Data sourced from openFDA. This site is unofficial and independent of the FDA.