Recall Z-0579-2017 ยท GBZ Catheter, Cholangiography
Atrium Medical Corporation
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
| Date | Oct 26, 2016 |
| Status | Terminated |
| Reason | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Root cause | Labeling design |
| Action | 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 replaceme |
| Quantity | 2172 cases (10/cs) |
| Distribution | 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 A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831931 | ATRIUM THORACIC CATHETER Atrium Medical Corp., Oct 4, 1983 |