Recall Z-0132-2017 ยท GBW Catheter, Peritoneal
ConMed Corporation
CORE Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
| 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
| K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO Core Dynamics, Inc., Nov 12, 1993 |