Recall Z-0105-2016— CooperSurgical, Inc.

Name: FDA recall Z-0105-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-01

Class III · Terminated

Class III FDA medical device recall by CooperSurgical, Inc., initiated 2015-09-01, terminated 2016-01-29. It names one FDA 510(k) clearance: K910253. Product: CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061. Reason: Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%).

Recalling firm: CooperSurgical, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-09-01
Terminated: 2016-01-29
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K910253 — LEEP REDIKITCooperSurgical, Inc.·cleared 1991-04-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.