Recall Z-0484-2024 ยท GBZ Catheter, Cholangiography
Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
| Date | Dec 2, 2023 (initiated Sep 29, 2023) |
| Status | Open, Classified |
| Reason | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Ti |
| Quantity | 2460 units (246 cases, 10 units/case) |
| Distribution | US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831931 | ATRIUM THORACIC CATHETER Atrium Medical Corp., Oct 4, 1983 |