Recall Z-1653-2009 ยท DQY Catheter, Percutaneous
Arrow International Inc
Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
| Date | Jul 7, 2009 (initiated Jun 17, 2009) |
| Status | Terminated |
| Reason | The spring wire guide is too large in diameter to pass through the needle, dilator and catheter. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 3019 units |
| Distribution | Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP Arrow Intl., Inc., Aug 25, 1986 |