Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
This recall has been terminated (originally issued October 4, 2016).
- Company
- Medtronic
- Recall Initiated
- October 4, 2016
- Terminated
- August 8, 2018
- Recall Number
- Z-0890-2017
- Quantity
- 230 systems
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Product sterility is compromised due to breach of the sterile barrier
Distribution
Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
Lot / Code Info
Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363 00Z2364 00Z2365 00Z2366 00Z2421 00Z2425 00Z2430 00Z2431 00Z2460 00Z2493 00Z2534 00Z2535 000Z2544 00Z5000B 00Z5001B GYNKIT2
Root Cause
Employee error
Action Taken
Covidien issued an Urgent Medical Device Recall letter on October 4, 2016 and a corrected letter on October 10, 2016 to US Customers via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices will be reworked. Questions or concerns, contact your Medtronic representative or customer service at 800-882-5878.