Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter l
FDA device recall Z-1653-2009 · posted 2009-07-07 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
- Action taken
- Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 3019 units
- Distribution
- Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
- Date initiated
- 2009-06-17
- Date posted
- 2009-07-07
- Date terminated
- 2009-12-03
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP (K862056) | Arrow Intl., Inc. | 1986-08-25 |