Recall Z-1965-2013 ยท DQY Catheter, Percutaneous
Arrow International Inc
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
| Date | Aug 14, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen. |
| Root cause | Labeling Change Control |
| Action | An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935. |
| Quantity | 156 |
| Distribution | AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL. |
| 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 |