Recall Z-2555-2019 ยท DYB Introducer, Catheter
Arrow International Inc
8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard technology is intended to help provide prote
| 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 | 520 eaches |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc., Oct 31, 2001 |