LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is

FDA device recall Z-1053-2013 · posted 2013-04-03 · Terminated

Recall details

Recalling firm

Cooper Surgical, Inc.

Reason for recall

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).

Action taken

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, please contact our Customer Service Department at 800-243-2974, or simply complete the attached form and fax to 800-262-0105. Arrangements will be made to replace product in your possession at CooperSurgical's expense. Further instruction and disposition of product will be communicated to you at that time. CooperSurgical deeply regrets the inconvenience that this problem has caused.

Root cause

Labeling mix-ups

Status

Terminated

Product code

MQB

Quantity affected

4395 kits

Distribution

Nationwide Distribution including Puerto Rico

Date initiated

2013-02-26

Date posted

2013-04-03

Date terminated

2014-06-12

Location

Trumbull, CT

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