Recall Z-1953-2018
Genesee BioMedical, Inc. · initiated February 26, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
Codes / lots: Serial Numbers: 1144 1145 707 709 959 404 1114 1151 520 621 784 1156 542 694 452 455 940 433 560 941 718 388 960 808 1045 1007 479 484 473 390 1067 1071 469 470 1054 977 626 967 494 1140 450 783 1194 853 920 273 368 1120 1121 1126 770 773 949 950 475 1021 1022 1159 877 680 769 370 1057 751 790 665 1092 1028 1118 981 585 586 582 993 1019 995 660 1094 1000 1001 1002 1003 1004 1034 1035 440 654 684 918 957 982 996 998 997 558 841 843 1100 238 731 369 854 526 187 489 568 695 992 677 1143 815 366 1182 1077 905 1044 1134 1046 564 1026 676 1040 1066 516 726 363 389 939 971 559 852 1080 566 599 600 522 1124 1150 628 629 909 796 990 903 916 917 1125 834 836 376 377 262 456 457 1115 490 1139 1160 774 789 822 833 476 403 1161 1164 1178 766 786 538 849 1078 1088 1093 451 471 782 215 356 807 1048 1073 937 1122 624 1225 591 1090 649 817 819 174 261 745 653 581 835 367 816 929 875 891 901 1123 804 842 933 578 434 1132 1133 923 787 375 912 924 1112 1136 1179 1180 619 620 637 675 708 801 947 571 572 573 1036 1085 951 1113 1165 1168 1170 1176 1177 562 651 797 814 826 828 829 926 931 935 540 551 552 679 803 794 553 678 802 811 812 813 821 686 954 1089 1138 595 598 721 757 907 908 910 911 913 1135…
Reason for recall
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.
FDA-determined cause: Component design/selection
Action taken
The customer communication letter, dated February 26, 2018, was mailed or emailed. The letter describes the concern and the user action. A copy of the revised Instructions for Use will be provided with the letter. All consignees in the US and outside of the US who have not been previously contacted will receive notification.
Details
- Recall number
- Z-1953-2018
- Initiated
- February 26, 2018
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 444 units
- Distribution
- Worldwide distribution. US nationwide, South Korea, Australia, COSTA RICA, Taiwan, New Zealand, Italy, Canada, Netherlands, Norway, Sweden, Switzerland, Israel, Japan, Egypt, South Africa, United Kingdom
- Recalling firm
- Genesee BioMedical, Inc., Denver, CO