Recall Z-2346-2015 ยท GBZ Catheter, Cholangiography
Atrium Medical Corporation
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
| Date | Aug 5, 2015 (initiated Jun 19, 2015) |
| Status | Terminated |
| Reason | Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter |
| Root cause | Employee error |
| Action | Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST). |
| Quantity | 62 cases (10/cs)=620 units |
| Distribution | AZ, CA, LA. IN, NC, TN, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831931 | ATRIUM THORACIC CATHETER Atrium Medical Corp., Oct 4, 1983 |