Recall Z-0131-2017 ยท GAZ Tubing, Noninvasive
ConMed Corporation
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
| Date | Jun 27, 2016 |
| Status | Terminated |
| Reason | 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 | Under Investigation by firm |
| Action | 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 aff |
| Distribution | Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES Core Dynamics, Inc., Jul 23, 1993 |