FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
- Recall number
- Z-0105-2016
- Recalling firm
- CooperSurgical, Inc.
- Product
- CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
- Status
- Terminated
- Initiated
- 2015-09-01
- Posted
- 2015-10-06
- Terminated
- 2016-01-29
- Reason
- Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
- 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
- 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.
- Lot, serial or model codes
- LOT 187889
- 510(k) numbers
- ["K910253"]
- PMA numbers
- not on file
- Product code
- HEE
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28