Recall Z-2556-2019 ยท DYB Introducer, Catheter
Arrow International Inc
Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.
| Date | Aug 6, 2019 |
| Status | Terminated |
| Reason | Products may contain the incorrect banner card within the kit |
| Root cause | Packaging process control |
| Action | Arrow International issued notification dated 8/6/19 stating problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers. 2. Inspect affected products within your control to confirm the product code on the lidstock matches the product code on the banner card of the same kit. Products confirmed to have an incorrect banner card should be returned to Arrow International. Products which properly match should not be returned. 3. If you have product with an incorrect banner card, plea |
| Quantity | 231 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.