Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Avalon Elite Vascular Access Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Avalon Elite Vascular Access Kitsee related information
Date Initiated by FirmFebruary 20, 2020
Create DateMarch 27, 2020
Recall Status1 Terminated 3 on January 18, 2022
Recall NumberZ-1603-2020
Recall Event ID 85104
510(K)NumberK081940 
Product Classification Dilator, vessel, for percutaneous catheterization - Product Code DRE
ProductAvalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Code Information Lot 19-03466
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactMs. Barb Smith
585-214-6049
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce255
DistributionDomestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRE
-
-