Z-1053-2013Class II

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

Name: Z-1053-2013 LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified...
Creator: Cooper Surgical, Inc.
Published: 2013-02-26
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2013-02-26 / Terminated / root cause: labeling and UDI

FDA source

Cooper Surgical, Inc. began a recall of 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... on 2013-02-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1053-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-26
Posted: 2013-04-03
Terminated: 2014-06-12
Recalling firm: CooperSurgical, Inc.
Product: 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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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).
Root cause tag: labeling and UDI
FDA 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, 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.
Quantity in commerce: 4395 kits
Distribution: Nationwide Distribution including Puerto Rico
Product codes and lots: Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1053-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1053-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-03

Product code MQB

K910253Class IILeep RedikitCooperSurgical, Inc. / cleared 1991-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)