CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
FDA device recall Z-0105-2016 · posted 2015-10-06 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
- Action taken
- CooperSurgical issued an "Recall Notification" dated September 1, 2015, to all affected customers via FedEX with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers asked to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for a free replacement. Contact Product Surveillance at 203.601.5200 ext. 3300
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- HEE
- Quantity affected
- 305 units
- Distribution
- US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.
- Date initiated
- 2015-09-01
- Date posted
- 2015-10-06
- Date terminated
- 2016-01-29
- 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 REDIKIT (K910253) | CooperSurgical, Inc. | 1991-04-18 |