Recall Z-1053-2013 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cooper Surgical, Inc.
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
| Date | Apr 3, 2013 (initiated Feb 26, 2013) |
| Status | Terminated |
| Reason | LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label). |
| Root cause | Labeling mix-ups |
| Action | CooperSurgical sent a Recall Notification dated February 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CSI intends to track and quarantine returned product in a segregated location at its manufacturing facility to ensure its separation from acceptable product and prevent its misuse. CSI intends to render used product useless by physical destruction and to rework unused product by correcting the labeling for redistribution. If you have any one of these affected lot numbers in your current inventory, plea |
| Quantity | 4395 kits |
| Distribution | Nationwide Distribution including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910253 | LEEP REDIKIT CooperSurgical, Inc., Apr 18, 1991 |