Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts
FDA device recall Z-1502-2009 · posted 2009-06-24 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
- Action taken
- Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 900,000 total, all products
- Distribution
- Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France,
- Date initiated
- 2009-02-11
- Date posted
- 2009-06-24
- Date terminated
- 2010-07-22
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD (K011056) | Arrow Intl., Inc. | 2001-10-24 |