Arrow International Inc Recall 87092
Description: Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Arrow International Inc Recall 87092 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1106-2021 |
| Event ID | 87092 |
| Event Description | Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 1,705 eaches |
| Recall Reason | The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction |
| Device Classification | 20210217 |
| Device Code Info | Lot Code: 13F20E0173 |
| Center Classification Date | 20210210 |
| Recall Initiation Date | 20210106 |
| Recalling Firm | Arrow International Inc |
| Initial Notification | Letter |
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