—#148414

Product

CORE Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for

FDA product code: GAZ — Tubing, Noninvasive
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K930512
Affected lot / code info: Beginning Lot Code 110609X to Ending Lot Code 20160308X

Why it was recalled

The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

ConMed sent an Urgent Device Recall letter dated June 27, 2016, to all affected customers with reply forms via USP First Class Mail. International customers received a notice dated July 11, 2016 by courier service. Customers were advised to inspect their inventory for any of the devices subject to recall. Customers were urged to contact all departments within their facility and any other facilities within their organization that may have received affected products. It is imperative that all end users of these devices receive the notification. Customers who have received any of the affected product are asked to complete and return the reply form along with the device to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac. Please do not return used devices. Replacement product will be issued unless otherwise requested. If customers do not have any affected devices to return, complete and return the business reply form indicating they have no devices and return by one of the means listed:1. Email to: coresihp@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team. Customers with questions or requests, should contact the Field Action Support Team at 315-624-3237, fax to 315-624-3225, or email coresihp@conmed.com.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

Timeline

Recall initiated: 2016-06-27
Terminated: 2018-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.