Z-0130-2017Class II

CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog...

Name: Z-0130-2017 CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog...
Creator: ConMed Corporation
Published: 2016-06-27
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2016-06-27 / Terminated / root cause: packaging

FDA source

ConMed Corporation began a recall of CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and... on 2016-06-27. FDA classified it as Class II and gives the reason as "The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0130-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-27
Posted: 2016-10-18
Terminated: 2018-06-07
Recalling firm: ConMed Corporation
Product: CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Product code: GBW Catheter, Peritoneal
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.
Root cause tag: packaging
FDA 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 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: [email protected] 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 [email protected].
Distribution: Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
Product codes and lots: Beginning Lot Code 110609X to Ending Lot Code 20160308X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0130-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0129-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0130-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0131-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0132-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0133-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0134-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0135-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

Product code GBW

K926477Class IBifurcated Suction/irrigat Tubing Set W/push ButtoCore Dynamics, Inc. / cleared 1993-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)