Recall Z-1850-2008
Atrium Medical Corporation · initiated May 12, 2008
Product
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top & Bottom, Atrium Code # 14509, Size 9mm, # Eyelets 9, 10 per case
Codes / lots: Lot 10311260
Reason for recall
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1850-2008
- Initiated
- May 12, 2008
- Posted by FDA
- August 14, 2008
- Terminated
- August 20, 2009
- Product code
- GBZ – Catheter, Cholangiography
- Quantity
- 6 cases (10 individual/case)
- Distribution
- Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
- Recalling firm
- Atrium Medical Corporation, Hudson, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1830-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1831-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1832-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1833-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1834-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1835-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1836-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1837-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1838-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparinc allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1839-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1840-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1841-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1842-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1843-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1844-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408, Size (Fr) 8, #…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1845-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, #…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1846-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428, Size (Fr) 28, #…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1847-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14120…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1848-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14124…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1849-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14132…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1851-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, Atrium…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly conminated with oversulfated… | 05/12/2008Terminated |
| Z-1852-2008 | HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |
| Z-1853-2008 | HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | 05/12/2008Terminated |