Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
FDA Recall Z-1603-2020 · Posted None
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Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDRE
Date Initiated2020-02-20
Date Terminated2022-01-18
Product Quantity255
Reason for Recall
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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