Recall Z-0105-2016 ยท HEE Set, Anesthesia, Paracervical
CooperSurgical, Inc.
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
| Date | Oct 6, 2015 (initiated Sep 1, 2015) |
| Status | Terminated |
| Reason | Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%) |
| Root cause | Labeling Change Control |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910253 | LEEP REDIKIT CooperSurgical, Inc., Apr 18, 1991 |