PlainRecalls
FDA Devices Moderate Class II Terminated

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Reported: October 26, 2016 Initiated: June 27, 2016 #Z-0129-2017

Product Description

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 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.

Details

Recalling Firm
ConMed Corporation
Units Affected
N/A
Distribution
Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
Location
Utica, NY

Frequently Asked Questions

What product was recalled?
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.. Recalled by ConMed Corporation. Units affected: N/A.
Why was this product recalled?
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0129-2017.