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U.S. Department of Health and Human Services

Class 2 Device Recall AngioSeal Evolution

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  Class 2 Device Recall AngioSeal Evolution see related information
Date Initiated by Firm April 09, 2018
Create Date June 29, 2018
Recall Status1 Terminated 3 on April 19, 2019
Recall Number Z-2337-2018
Recall Event ID 80242
PMA Number P930038 
Product Classification Device, hemostasis, vascular - Product Code MGB
Product Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Code Information 5980075, 5980077
Recalling Firm/
Manufacturer		 Terumo Medical Corp
2101 Cottontail Ln
Somerset NJ 08873-1277
For Additional Information Contact Ms. Nancy Leclair
732-412-4163
Manufacturer Reason
for Recall		 Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action On April 9, 2018, the firm sent Urgent Voluntary Medical Device Recall letters and Inventory Confirmation Forms to customers via FedEx. The letter described the product issue. Customers were asked to: 1. Review your Angio-Seal Evolution inventory immediately to identify and isolate affected inventory in order to prevent future use. 2. Your Terumo Territory Manager will visit your facility to confirm product inventory and assist you in completing the enclosed Recall Acknowledgement/ Inventory Confirmation Form. This required documentation, along with the enclosed Fed-Ex product shipment labels will facilitate your return of affected Angio-Seal Evolution product to Terumo Medical Corporation.
Quantity in Commerce 240
Distribution Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = MGB and Original Applicant = TERUMO MEDICAL CORPORATION
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