Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions
FDA device recall Z-0639-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- catheter slips out of the suture wing during use.
- Action taken
- The recalling firm issued a recall letter dated 2/18/04 to their direct accounts informing them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- MPB
- Quantity affected
- 6610 UNITS
- Distribution
- The product was shipped to hospitals, medical supply companies, and sales representatives nationwide. Products were also shipped to England, Belgium, Germany, Greece, Sweden, Ukraine, France, Taiwan,
- Date initiated
- 2004-02-18
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-19
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO (K993933) | Arrow Intl., Inc. | 2000-09-14 |
| 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT (K991431) | Arrow Intl., Inc. | 1999-05-26 |