Recall Z-0019-2011 ยท GBS Catheter, Ventricular, General & Plastic Surgery
Atrium Medical Corporation
HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
| Date | Oct 7, 2010 (initiated Aug 10, 2010) |
| Status | Terminated |
| Reason | Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters. |
| Root cause | Packaging process control |
| Action | Atrium Medical isued Product Recall Notice letters dated August 10, 2010 to customers, identifying the affected product and actions to be taken by customers. Customers were instructed to remove the affected products from inventory and return them to Atrium, and complete and fax a recall notice acknowledgement to Atriuim at 603-821-1420. Customers can contact Atrium at 800 528-7486, x5350 (Joe DePaolo) or x5351 (Karen Hall) for further information. |
| Quantity | 10 cases, 10/case |
| Distribution | Nationwide Distribution: USA, including the states of AK, CT, OH, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.