Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Recall
- Recall Number
- Z-0577-2017
- Event Number
- 75347
- Firm
- Atrium Medical Corporation
- FEI Number
- 3011175548
- Product Code
- GBZ
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- October 26, 2016
- Terminated
- October 9, 2018
- Address
- 5 Wentworth Dr, Hudson, NH, 03051-4929
Description
Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Atrium Medical issued an "Urgent Medical Device Recall (Removal)" communication to customers on 10/26/16 via FedEx 2 day delivery. The recall identifies the problem, product, and risk factors. In addition, it provides instructions on how to handle product that may be affected. Accounts are to read the letter completely and share with all users and staff. They have been requested to complete the enclosed Recall Reply Form, acknowledging receipt of the notice; and, remove and quarantine any affected product for return. Additionally, obtain product from an alternate supplier because replacement product is not available as all Trocar catheters have been discontinued. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm, for a Return Goods Authorization to return the product and receive credit.
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
2822 cases (10/cs)