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U.S. Department of Health and Human Services

Class 2 Device Recall HEMASHIELD PLATINUM Woven Double Velour Vascular Graft

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  Class 2 Device Recall HEMASHIELD PLATINUM Woven Double Velour Vascular Graft see related information
Date Initiated by Firm August 22, 2019
Create Date September 24, 2019
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-2559-2019
Recall Event ID 83664
510(K)Number K021213  
Product Classification Graft, vascular, synthetic/biologic composite - Product Code MAL
Product The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a
softening agent.
Code Information Lot Code: 18K31 Serial Number: 1190443415 Part Number: M00202166168P0 UDI Code: 00384401018452
Recalling Firm/
Manufacturer		 GETINGE US SALES LLC
45 BARBOUR POND DR
WAYNE NJ 07470
For Additional Information Contact Rachana Patel
973-709-7412
Manufacturer Reason
for Recall		 Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
FDA Determined
Cause 2		 Under Investigation by firm
Action 1. Please examine your inventory immediately to determine if you have the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product. 2. Please remove the affected product from areas of use. 3. Affected product should be returned to Getinge per the following process: ¿ Please complete the Urgent Medical Device Recall  Removal Response Form to acknowledge that you have received this Urgent Medical Device Recall  Removal letter. ¿ Please fax or email the completed form to Getinge office as instructed on the form. ¿ Please contact Getinge Customer Service at 18886278383 (press option 2, then option 5) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a shipping instructions to return any affected product. ¿ Pack the product to be returned with the appropriate return documents. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at +1 8886278383 (press option 2, then option 5), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)
Quantity in Commerce 1 unit
Distribution US state of NJ
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.
510(K) Database 510(K)s with Product Code = MAL and Original Applicant = BOSTON SCIENTIFIC CORP.
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