HEMASHIELD 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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Maquet Cardiovascular, LLC
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

HEMASHIELD 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1873-2020

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