Recall Z-0560-2019 ยท GBZ Catheter, Cholangiography
Atrium Medical Corporation
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
| Date | Oct 12, 2018 |
| Status | Terminated |
| Reason | This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of th |
| Root cause | Vendor change control |
| Action | The firm notified affected customers on October 29, 2018 via an Urgent Medical Device Recall letter. The letter alerted customers to the issue of the product's sterile barrier pouch not being properly sealed at the bottom. Customers were asked to do the following: 1. Examine your inventory to determine if you have the affected product listed in this Notification. If so, remove affected products, quarantine them, and place in a secure location. 2. If you have affected product, contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm (EST), fo |
| Quantity | 2930 units |
| Distribution | Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831931 | ATRIUM THORACIC CATHETER Atrium Medical Corp., Oct 4, 1983 |