Recall Z-1837-2008 ยท GBS Catheter, Ventricular, General & Plastic Surgery
Atrium Medical Corporation
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case
| Date | Aug 14, 2008 (initiated May 12, 2008) |
| Status | Terminated |
| Reason | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| Root cause | Nonconforming Material/Component |
| Action | Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice. |
| Quantity | 33 cases (10 individual/case) |
| Distribution | Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912645 | ATRIUMS PDR THORACIC CATHETER Atrium Medical Corp., Sep 13, 1991 |