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 HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS

  • 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 HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTSsee related information
Date Initiated by FirmApril 07, 2020
Create DateMay 04, 2020
Recall Status1 Terminated 3 on November 05, 2021
Recall NumberZ-1873-2020
Recall Event ID 85420
510(K)NumberK021213 
Product Classification Graft, vascular, synthetic/biologic composite - Product Code MAL
ProductHEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Code Information Serial Numbers: 1069844373 1069859235 1070838372 1070706306 1070885876 1070696535 1070880206 1070698932 1070693359 1070875260 1070859895 1071599689 1071623404 1071635929 1071640855 1071595383 1072244650 1072221218 1072235164 1073312349 1074236187 1074521366 1075883407 1076662460 1076662089 1076657163 1076657651 1077516221 1077516455 1077512637 1077509366 1077515793 1077506795 1077514292 1077510006 1077509132 1080021177 1080028425 1080022190 1080038065 1080016505 1080020047 1080020906 1080022444 1080034247 1080026145 1107350739 1107370878 1107397055 1107542300 1107356954 1107534803 1111727076 1111767628 1111828116 1111802952 1111831484 1111976640 1111962791 1111974477 1111985521 1111988794 1111989573 1111991831 1111960882 1111934296 1113454547 1113439727 1113459983 1113457606 1113464792 1113410548 1113473439 1115874978 1115872835 1115914782 1115896441 1115917119 1115900231 1115900953 1115936616 1115917841 1115915444 1115918249 1116670546 1116664587 1116654947 1116679332 1116771449 1116675865 1116657147 1117803878 1117890119 1117889596 1123969330 1123996558 1124010762 1123975523 1123968785 1124016489 1124033238 1123954839 1124030667 1123982592 1124038069 1123990226 1124016977 1126833792 1129566390 1129565748 1131391775 1134353909 1134350733 1134353284 1134370267 1139544111 1139533926 1139541540 1139536009 1146817477 1150356075 1151513850 1151507306 1151527816 1151544428 1169424559 1169388690 1171544434 1171540733 1171618089 1171564710 1171541375 1173579328 1173699240 1182769446 1182698342 1182756864 1182709126 1184446354 1184412971 1184445946 1184453326 1184450033 1187301116 1187336000 1187866556 1189130132 1189111006 1190531014 1190781708
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
FDA Determined
Cause 2		Process design
ActionGetinge issued a customer notification - Urgent Medical Device Removal on April 7, 2020 via FedEx 2-day delivery with signature required. Letter states reason for recall, health risk, and action to take: Examine your inventory immediately to determine if you have any affected HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft and/or HEMASHIELD PLATINUM Woven Double Velour Vascular Graft products. If you have affected product that are listed in attachment 1 on page 5, please remove the affected products from areas of use. "If you have affected product to return, please contact Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. Please fill out the customer response form on page 4 with the required information. "Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided. Please arrange for pickup with the designated delivery service provider. Whether you have the affected product or not, please complete and return the form (page 4) to acknowledge this recall by e-mailing a scanned copy to Hemashield2020.ACT@getinge.com or by faxing the form to (973) 807-9205 Questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time.
DistributionWorldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
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 = MAL
-
-