Z-0105-2016Class III

CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure...

Name: Z-0105-2016 CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure...
Creator: CooperSurgical, Inc.
Published: 2015-09-01
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-09-01 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061 on 2015-09-01. FDA classified it as Class III and gives the reason as "Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)". 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-0105-2016
Classification: Class III
Status: Terminated
Initiated: 2015-09-01
Posted: 2015-10-06
Terminated: 2016-01-29
Recalling firm: CooperSurgical, Inc.
Product: CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Product code: HEE Set, Anesthesia, Paracervical
Reason for recall: Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: LOT 187889

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0105-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0105-2016	Class III	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-06

Product code HEE

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)