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 Intende
FDA device recall Z-0484-2015 · posted 2014-12-02 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
- Action taken
- CooperSurgical issued recall letter dated October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form. Customers with questions were instructed to call 203-601-5200.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HGI
- Quantity affected
- 595 units
- Distribution
- Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
- Date initiated
- 2014-10-27
- Date posted
- 2014-12-02
- Date terminated
- 2015-05-29
- Location
- Trumbull, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR (K905747) | Coopervision Surgical | 1991-09-17 |