Recall Z-1603-2020 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Maquet Cardiovascular Us Sales, Llc
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
| Date | Feb 20, 2020 |
| Status | Terminated |
| Reason | A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle. |
| Root cause | Under Investigation by firm |
| Action | On February 20, 2020, the recalling firm notified affected customers via Urgent Medical Device Recall letters sent through FedEx. Customers were informed of the material mix-up with the needle portion of the kit. Customers were instructed to immediately examine their inventory to determine if they have any of the affected lot. If so, please remove the kits from areas of use and return the product to Getinge following the instructions in the letter. Unused and unexpired affected product that is returned to Getinge is eligible for full credit. |
| Quantity | 255 |
| Distribution | Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081940 | AVALON ELITE VASCULAR ACCESS KIT Avalon Laboratories, LLC, Nov 18, 2008 |