ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CSD-15552-I, Intended f
FDA device recall Z-2285-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The tips may not have been adequately welded to the catheter body.
- Action taken
- Consignees were notified by letter on/about 06/10/2008. They were instructed to: 1. Cease use and distribution and quarantine all affected product immediately. 2. Contact Arrows Customer Service Department for a Return Authorization Number, enter the number on an enclosed Recall Acknowledgement & Stock Status Form and 3. Immediately fax back the form to Arrow International. All affected product is to be returned to Arrow International. A letter containing the recall information was enclosed for physicians who have implanted catheters. Contact Arrow's Customer Service at 1-800-523-8446 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 79248 units (total for all catheters listed)
- Distribution
- U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, In
- Date initiated
- 2008-06-10
- Date posted
- 2008-09-17
- Date terminated
- 2009-12-03
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTEGRAL HEMODIALYSIS CATHETER (K040260) | Arrow Int'L. | 2004-03-05 |