HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9024, Size (Fr) 24,
FDA device recall Z-1833-2008 · posted 2008-08-14 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GBS
- Quantity affected
- 41 cases (10 individual/case)
- Distribution
- Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
- Date initiated
- 2008-05-12
- Date posted
- 2008-08-14
- Date terminated
- 2009-08-20
- Location
- Hudson, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRIUMS PDR THORACIC CATHETER (K912645) | Atrium Medical Corp. | 1991-09-13 |