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Terminated

CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

FDA Recall Z-0105-2016 · Posted 2015-10-06

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHEE
Date Initiated2015-09-01
Date Terminated2016-01-29
Product Quantity305 units

Reason for Recall

Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)

Firm 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

Root Cause

Labeling Change Control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910253LEEP REDIKITCooperSurgical, Inc. · 1991-04-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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