Recall Z-3299-2024 ยท DQX Wire, Guide, Catheter
ARROW INTERNATIONAL Inc.
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm
| Date | Sep 26, 2024 (initiated Jul 26, 2024) |
| Status | Open, Classified |
| Reason | Reports have been received regarding open seals on the packaging. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters dated July-2024 via Fed Ex 2-day mail on 7/26/2024. The letter provided a description of the problem and immediate actions required. Medical facilities were requested to immediately check their inventory for the affected product and cease use and distribution of it. The product is to be quarantined immediately. If the facility has the impacted product, they are to indicate so on the Acknowledgement Form enclosed with the letter and FAX it to the firm. A customer service representative will contact the medical facility with a Return Goods Authorization (R |
| Quantity | 14,845 kits |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution. |
| FDA record | Open on fda.gov |