Recall Z-0133-2017— ConMed Corporation

Name: FDA recall Z-0133-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-27

Class II · Terminated

Class II FDA medical device recall by ConMed Corporation, initiated 2016-06-27, terminated 2018-06-07. It names one FDA 510(k) clearance: K926477. Product: CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.. Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product..

Recalling firm: ConMed Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-06-27
Terminated: 2018-06-07
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K926477 — BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTOCore Dynamics, Inc.·cleared 1993-11-12

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

CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Reason for recall

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

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