Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indi...
FDA Device Recall #Z-0765-2017 — Class II — November 11, 2016
Recall Summary
| Recall Number | Z-0765-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 11, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Sustainability Solutions |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 40,476 devices |
Product Description
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Reason for Recall
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA
Lot / Code Information
Model Lot Manufacture Date Expiration H12LP 3 5 3 6 585 3/3/2015 Mar-18 H12LP 3 5 3 6 880 3/3/2015 Mar-18 H12LP 3 5 3 9 579 3/3/2015 Mar-18 H12LP 3 5 4 0 175 3/5/2015 Mar-18 H12LP 3 5 4 2 016 3/5/2015 Mar-18 H12LP 3 5 4 3 606 3/5/2015 Mar-18 H12LP 3 5 4 3 610 3/9/2015 Mar-18 H12LP 3 5 4 6 115 3/9/2015 Mar-18 H12LP 3 5 4 6 751 3/9/2015 Mar-18 H12LP 3 5 4 6 767 3/9/2015 Mar-18 H12LP 3 5 4 8 518 3/11/2015 Mar-18 H12LP 3 5 4 8 368 3/13/2015 Mar-18 H12LP 3 5 4 9 294 3/13/2015 Mar-18 H12LP 3 5 4 9 583 3/13/2015 Mar-18 H12LP 3 5 5 7 373 3/16/2015 Mar-18 H12LP 3 5 5 9 424 3/16/2015 Mar-18 H12LP 3 5 5 9 453 3/16/2015 Mar-18 H12LP 3 5 6 0 044 3/16/2015 Mar-18 H12LP 3 5 6 0 160 3/16/2015 Mar-18 H12LP 3 5 6 1 254 3/16/2015 Mar-18 H12LP 3 5 6 1 368 3/16/2015 Mar-18 H12LP 3 5 6 1 797 3/16/2015 Mar-18 H12LP 3 5 6 2 147 3/16/2015 Mar-18 H12LP 3 5 6 2 759 3/16/2015 Mar-18 H12LP 3 5 6 2 771 3/16/2015 Mar-18 H12LP 3 5 6 4 013 3/16/2015 Mar-18 H12LP 3 5 6 7 588 3/20/2015 Mar-18 H12LP 3 5 6 9 977 3/20/2015 Mar-18 H12LP 3 5 7 2 483 3/20/2015 Mar-18 H12LP 3 5 7 3 055 3/20/2015 Mar-18 H12LP 3 5 7 4 237 3/23/2015 Mar-18 H12LP 3 5 7 4 758 3/23/2015 Mar-18 H12LP 3 5 7 6 241 3/26/2015 Mar-18 H12LP 3 5 7 6 256 3/26/2015 Mar-18 H12LP 3 5 7 8 827 3/26/2015 Mar-18 H12LP 3 5 7 9 519 3/27/2015 Mar-18 H12LP 3 5 8 1 796 3/27/2015 Mar-18 H12LP 3 5 8 4 936 3/27/2015 Mar-18 H12LP 3 5 8 5 050 3/27/2015 Mar-18 H12LP 3 5 8 5 045 3/31/2015 Mar-18 H12LP 3 5 9 0 552 3/31/2015 Mar-18 H12LP 3 5 9 1 204 3/31/2015 Mar-18 H12LP 3 5 9 5 638 4/6/2015 Apr-18 H12LP 3 6 0 0 132 4/6/2015 Apr-18 H12LP 3 5 9 5 640 4/9/2015 Apr-18 H12LP 3 5 9 8 881 4/9/2015 Apr-18 H12LP 3 6 0 0 653 4/9/2015 Apr-18 H12LP 3 6 1 8 260 4/23/2015 Apr-18 H12LP 3 6 0 0 885 4/28/2015 Apr-18 H12LP 3 6 0 1 108 4/28/2015 Apr-18 H12LP 3 6 2 7 407 4/28/2015 Apr-18 H12LP 3 6 0 0 956 4/29/2015 Apr-18 H12LP 3 6 1 8 738 5/4/2015 May-18 H12LP 3 6 1 8 740 5/4/2015 May-18 H12LP 3 6 2 1 258 5/4/2015 May-18 H12LP 3 6 2 1 270 5/4/2015 May-18 H12LP 3 6 2 1 465 5/4/2015 May-18 H12LP 3 6 2 2 983 5/4/2015 May-18 H12LP 3 6 2 3 066 5/4/2015 May-18 H12LP 3 6 2 5 266 5/4/2015 May-18 H12LP 3 6 2 5 278 5/4/2015 May-18 H12LP 3 6 2 6 334 5/4/2015 May-18 H12LP 3 6 2 6 368 5/4/2015 May-18 H12LP 3 6 2 6 967 5/4/2015 May-18 H12LP 3 6 2 9 293 5/4/2015 May-18 H12LP 3 6 3 0 383 5/4/2015 May-18 H12LP 3 6 2 7 257 5/6/2015 May-18 H12LP 3 6 2 7 411 5/6/2015 May-18 H12LP 3 6 3 0 752 5/6/2015 May-18 H12LP 3 6 3 0 768 5/6/2015 May-18 H12LP 3 6 3 2 514 5/6/2015 May-18 H12LP 3 6 3 3 784 5/6/2015 May-18 H12LP 3 6 3 1 516 5/8/2015 May-18 H12LP 3 6 3 3 922 5/8/2015 May-18 H12LP 3 6 4 2 785 5/8/2015 May-18 H12LP 3 6 4 2 841 5/8/2015 May-18 H12LP 3 6 4 2 650 5/11/2015 May-18 H12LP 3 6 4 3 660 5/11/2015 May-18 H12LP 3 6 4 3 694 5/11/2015 May-18 H12LP 3 6 4 4 701 5/11/2015 May-18 H12LP 3 6 4 6 364 5/11/2015 May-18 H12LP 3 6 4 7 952 5/11/2015 May-18 H12LP 3 6 4 7 968 5/11/2015 May-18 H12LP 3 6 4 8 893 5/11/2015 May-18 H12LP 3 6 4 8 903 5/11/2015 May-18 H12LP 3 6 3 3 933 5/13/2015 May-18 H12LP 3 6 5 1 572 5/13/2015 May-18 H12LP 3 6 5 1 586 5/13/2015 May-18 H12LP 3 6 4 4 729 5/15/2015 May-18 H12LP 3 6 5 4 744 5/15/2015 May-18 H12LP 3 6 5 5 084 5/15/2015 May-18 H12LP 3 6 5 5 097 5/15/2015 May-18 H12LP 3 6 5 6 718 5/15/2015 May-18 H12LP 3 6 5 6 725 5/15/2015 May-18 H12LP 3 6 6 0 049 5/18/2015 May-18 H12LP 3 6 6 2 085 5/18/2015 May-18 H12LP 3 5 9 1 178 5/21/2015 May-18 H12LP 3 5 9 4 312 5/21/2015 May-18 H12LP 3 6 6 2 403 5/21/2015 May-18 H12LP 3 6 6 9 729 5/22/2015 May-18 H12LP 3 6 7 7 361 5/22/2015 May-18 H12LP 3 6 7 8 137 5/22/2015 May-18 H12LP 3 6 7 8 171 5/22/2015 May-18 H12LP 3 6 7 9 918 5/22/2015 May-18 H12LP 3 6 7 9 939 5/27/2015 May-18 H12LP 3 6 8 0 287 5/27/2015 May-18 H12LP 3 6 8 0 959 5/27/2015 May-18 H12LP 3 6 7 2 428 5/28/2015 May-18 H12LP 3 6 8 0 577 5/28/2015 May-18 H12LP 3 6 9 2 959 6/1/2015 Jun-18 H12LP 3 6 9 8 936 6/4/2015 Jun-18 H12LP 3 6 9 8 943 6/4/2015 Jun-18 H12LP 3 7 0 3 025 6/4/2015 Jun-18 H12LP 3 7 0 7 017 6/4/2015 Jun-18 H12LP 3 7 0 8 496 6/5/2015 Jun-18 H12LP 3 7 0 8 546 6/5/2015 Jun-18 H12LP 3 7 1 0 388 6/5/2015 Jun-18 H12LP 3 7 1 0 498 6/5/2015 Jun-18 H12LP 3 7 1 1 263 6/5/2015 Jun-18 H12LP 3 7 1 2 572 6/5/2015 Jun-18 H12LP 3 7 1 2 909 6/5/2015 Jun-18 H12LP 3 7 1 2 913 6/9/2015 Jun-18 H12LP 3 7 1 3 407 6/9/2015 Jun-18 H12LP 3 7 1 3 901 6/9/2015 Jun-18 H12LP 3 7 1 4 983 6/9/2015 Jun-18 H12LP 3 7 1 5 570 6/9/2015 Jun-18 H12LP 3 7 1 5 589 6/9/2015 Jun-18 H12LP 3 7 1 6 638 6/9/2015 Jun-18 H12LP 3 7 1 5 074 6/11/2015 Jun-18 H12LP 3 7 1 7 973 6/11/2015 Jun-18 H12LP 3 7 1 9 225 6/11/2015 Jun-18 H12LP 3 7 2 0 057 6/11/2015 Jun-18 H12LP 3 7 2 2 329 6/15/2015 Jun-18 H12LP 3 7 2 5 181 6/15/2015 Jun-18 H12LP 3 7 2 6 772 6/15/2015 Jun-18 H12LP 3 7 2 7 435 6/15/2015 Jun-18 H12LP 3 7 3 0 715 6/17/2015 Jun-18 H12LP 3 7 3 1 099 6/17/2015 Jun-18 H12LP 3 7 3 2 833 6/17/2015 Jun-18 H12LP 3 7 3 2 851 6/17/2015 Jun-18 H12LP 3 7 3 2 898 6/17/2015 Jun-18 H12LP 3 7 3 7 917 6/19/2015 Jun-18 H12LP 3 7 4 1 225 6/22/2015 Jun-18 H12LP 3 7 4 1 256 6/22/2015 Jun-18 H12LP 3 7 4 2 041 6/22/2015 Jun-18 H12LP 3 7 4 4 436 6/22/2015 Jun-18 H12LP 3 7 4 6 004 6/22/2015 Jun-18 H12LP 3 7 4 8 349 6/24/2015 Jun-18 H12LP 3 7 5 1 993 6/29/2015 Jun-18 H12LP 3 7 5 2 003 6/29/2015 Jun-18 H12LP 3 7 5 8 494 6/29/2015 Jun-18 H12LP 3 7 5 9 302 6/29/2015 Jun-18 H12LP 3 7 5 9 534 6/29/2015 Jun-18 H12LP 3 7 6 0 136 6/30/2015 Jun-18 H12LP 3 7 6 2 495 6/30/2015 Jun-18 H12LP 3 7 6 2 972 6/30/2015 Jun-18 H12LP 3 7 6 5 649 6/30/2015 Jun-18 H12LP 3 7 6 8 045 7/6/2015 Jul-18 H12LP 3 7 6 9 980 7/6/2015 Jul-18 H12LP 3 7 7 1 161 7/6/2015 Jul-18 H12LP 3 7 7 5 668 7/8/2015 Jul-18 H12LP 3 7 7 5 681 7/8/2015 Jul-18 H12LP 3 7 7 9 516 7/8/2015 Jul-18 H12LP 3 7 8 3 776 7/10/2015 Jul-18 H12LP 3 7 8 6 146 7/10/2015 Jul-18 H12LP 3 7 8 6 957 7/10/2015 Jul-18 H12LP 3 7 7 8 024 7/13/2015 Jul-18 H12LP 3 7 8 2 202 7/13/2015 Jul-18 H12LP 3 7 8 4 430 7/13/2015 Jul-18 H12LP 3 7 9 2 212 7/15/2015 Jul-18 H12LP 3 7 9 4 403 7/15/2015 Jul-18 H12LP 3 7 9 4 419 7/15/2015 Jul-18 H12LP 3 7 9 9 917 7/16/2015 Jul-18 H12LP 3 7 9 9 929 7/16/2015 Jul-18 H12LP 3 8 0 0 013 7/16/2015 Jul-18 H12LP 3 8 0 3 761 7/20/2015 Jul-18 H12LP 3 8 0 3 918 7/20/2015 Jul-18 H12LP 3 8 0 4 868 7/20/2015 Jul-18 H12LP 3 8 0 7 840 7/22/2015 Jul-18 H12LP 3 8 0 9 891 7/22/2015 Jul-18 H12LP 3 8 1 0 037 7/22/2015 Jul-18 H12LP 3 8 1 0 783 7/22/2015 Jul-18 H12LP 3 8 1 0 806 7/22/2015 Jul-18 H12LP 3 8 1 1 525 7/23/2015 Jul-18 H12LP 3 8 1 1 778 7/23/2015 Jul-18 H12LP 3 8 1 3 019 7/23/2015 Jul-18 H12LP 3 8 1 3 042 7/23/2015 Jul-18 H12LP 3 8 1 5 917 7/28/2015 Jul-18 H12LP 3 8 1 6 258 7/28/2015 Jul-18 H12LP 3 8 1 7 655 7/29/2015 Jul-18 H12LP 3 8 2 0 257 7/29/2015 Jul-18 H12LP 3 8 2 1 740 7/29/2015 Jul-18 H12LP 3 8 1 8 770 7/30/2015 Jul-18 H12LP 3 8 2 2 395 7/30/2015 Jul-18 H12LP 3 8 2 3 167 7/30/2015 Jul-18 H12LP 3 8 2 8 192 7/30/2015 Jul-18 H12LP 3 8 2 8 222 7/30/2015 Jul-18 H12LP 3 8 3 0 778 7/30/2015 Jul-18 H12LP 3 8 2 9 338 8/5/2015 Aug-18 H12LP 3 8 3 1 629 8/5/2015 Aug-18 H12LP 3 8 3 3 206 8/7/2015 Aug-18 H12LP 3 8 3 4 196 8/7/2015 Aug-18 H12LP 3 8 3 4 203 8/7/2015 Aug-18 H12LP 3 8 4 1 494 8/10/2015 Aug-18 H12LP 3 8 4 3 375 8/10/2015 Aug-18 H12LP 3 8 4 6 698 8/10/2015 Aug-18 H12LP 3 8 4 5 650 8/12/2015 Aug-18 H12LP 3 8 4 8 891 8/12/2015 Aug-18 H12LP 3 8 4 9 655 8/12/2015 Aug-18 H12LP 3 8 5 2 513 8/12/2015 Aug-18 H12LP 3 8 5 3 141 8/17/2015 Aug-18 H12LP 3 8 5 4 774 8/17/2015 Aug-18 H12LP 3 8 6 1 804 8/19/2015 Aug-18 H12LP 3 8 6 3 303 8/21/2015 Aug-18 H12LP 3 8 6 4 693 8/21/2015 Aug-18 H12LP 3 8 7 0 240 8/24/2015 Aug-18 H12LP 3 8 6 6 398 8/26/2015 Aug-18 H12LP 3 8 7 3 578 8/26/2015 Aug-18 H12LP 3 8 7 9 078 8/26/2015 Aug-18 H12LP 3 8 8 1 364 8/26/2015 Aug-18 H12LP 3 8 8 6 277 8/26/2015 Aug-18 H12LP 3 8 8 0 942 8/28/2015 Aug-18 H12LP 3 8 9 0 070 8/28/2015 Aug-18 H12LP 3 8 9 0 089 8/28/2015 Aug-18 H12LP 3 8 9 1 092 8/28/2015 Aug-18 H12LP 3 8 9 4 286 8/31/2015 Aug-18 H12LP 3 8 9 4 678 8/31/2015 Aug-18 H12LP 3 8 9 6 022 8/31/2015 Aug-18 H12LP 3 8 9 7 381 8/31/2015 Aug-18 H12LP 3 9 0 1 817 9/2/2015 Sep-18 H12LP 3 9 1 9 589 9/10/2015 Sep-18 H12LP 3 9 2 3 533 9/10/2015 Sep-18 H12LP 4 0 7 0 594 11/2/2015 Nov-18 H12LP 4 0 7 1 923 11/2/2015 Nov-18 H12LP 4 0 8 6 802 11/6/2015 Nov-18 H12LP 4 1 0 8 634 11/16/2015 Nov-18 H12LP 4 1 0 9 934 11/16/2015 Nov-18 H12LP 4 1 1 3 667 11/20/2015 Nov-18 H12LP 4 1 1 8 604 11/20/2015 Nov-18 H12LP 4 1 1 7 718 11/25/2015 Nov-18 H12LP 4 1 3 3 825 11/25/2015 Nov-18 H12LP 4 1 3 8 769 11/25/2015 Nov-18 H12LP 4 1 4 7 801 11/30/2015 Nov-18 H12LP 3 8 4 9 330 12/3/2015 Dec-18 H12LP 4 1 5 4 685 12/4/2015 Dec-18 H12LP 4 1 5 8 429 12/4/2015 Dec-18 H12LP 4 1 7 0 275 12/9/2015 Dec-18 H12LP 4 1 7 3 170 12/9/2015 Dec-18 H12LP 4 1 7 8 006 12/9/2015 Dec-18 H12LP 4 1 7 9 279 12/9/2015 Dec-18 H12LP 4 1 8 7 693 12/11/2015 Dec-18 H12LP 4 1 9 8 853 12/16/2015 Dec-18 H12LP 4 2 0 2 332 12/16/2015 Dec-18 H12LP 4 2 3 5 633 1/5/2016 Jan-19 H12LP 4 2 4 5 630 1/8/2016 Jan-19 H12LP 4 2 7 4 018 1/18/2016 Jan-19 H12LP 4 2 8 2 444 1/22/2016 Jan-19 H12LP 4 3 8 6 368 3/3/2016 Mar-19 H12LP 4 4 0 1 698 3/9/2016 Mar-19 H12LP 4 5 1 2 285 4/29/2016 Apr-19 H12LP 4 5 1 3 266 4/29/2016 Apr-19 H12LP 4 5 1 5 596 5/2/2016 May-19 H12LP 4 5 1 8 648 5/2/2016 May-19 H12LP 4 5 1 8 607 5/4/2016 May-19 H12LP 4 5 2 4 457 5/4/2016 May-19 H12LP 4 5 2 8 655 5/6/2016 May-19 H12LP 4 5 2 9 566 5/6/2016 May-19 H12LP 4 5 3 0 457 5/6/2016 May-19 H12LP 4 5 3 1 659 5/6/2016 May-19 H12LP 4 5 3 3 116 5/6/2016 May-19 H12LP 4 5 3 9 867 5/9/2016 May-19 H12LP 4 5 4 1 625 5/11/2016 May-19 H12LP 4 5 4 5 105 5/11/2016 May-19 H12LP 4 5 4 5 612 5/11/2016 May-19 H12LP 4 5 4 5 198 5/13/2016 May-19 H12LP 4 5 4 8 729 5/13/2016 May-19 H12LP 4 5 4 8 738 5/13/2016 May-19 H12LP 4 5 5 1 779 5/13/2016 May-19 H12LP 4 5 5 1 780 5/13/2016 May-19 H12LP 4 5 5 7 026 5/16/2016 May-19 H12LP 4 5 6 1 287 5/18/2016 May-19 H12LP 4 5 6 2 934 5/18/2016 May-19 H12LP 4 4 5 8 288 5/20/2016 May-19 H12LP 4 4 5 9 232 5/20/2016 May-19 H12LP 4 4 6 0 302 5/20/2016 May-19 H12LP 4 4 6 6 103 5/20/2016 May-19 H12LP 4 4 6 6 644 5/20/2016 May-19 H12LP 4 4 6 7 337 5/20/2016 May-19 H12LP 4 4 6 9 802 5/20/2016 May-19 H12LP 4 4 7 0 971 5/20/2016 May-19 H12LP 4 4 7 3 956 5/20/2016 May-19 H12LP 4 4 7 3 960 5/20/2016 May-19 H12LP 4 4 7 4 932 5/20/2016 May-19 H12LP 4 4 7 4 945 5/20/2016 May-19 H12LP 4 4 7 6 349 5/20/2016 May-19 H12LP 4 4 7 7 829 5/20/2016 May-19 H12LP 4 4 7 9 578 5/20/2016 May-19 H12LP 4 5 6 6 912 5/20/2016 May-19 H12LP 4 5 6 7 856 5/20/2016 May-19 H12LP 4 5 7 2 487 5/23/2016 May-19 H12LP 4 5 7 4 907 5/23/2016 May-19 H12LP 4 5 7 5 693 5/23/2016 May-19 H12LP 4 5 7 5 705 5/23/2016 May-19 H12LP 4 5 7 1 871 5/25/2016 May-19 H12LP 4 5 7 4 911 5/25/2016 May-19 H12LP 4 5 7 6 086 5/25/2016 May-19 H12LP 4 5 7 6 443 5/25/2016 May-19 H12LP 4 5 7 6 462 5/25/2016 May-19 H12LP 4 5 7 7 392 5/25/2016 May-19 H12LP 4 5 7 7 407 5/25/2016 May-19 H12LP 4 5 8 1 177 5/25/2016 May-19 H12LP 4 5 8 0 431 5/27/2016 May-19 H12LP 4 5 8 1 725 5/27/2016 May-19 H12LP 4 5 8 3 479 5/27/2016 May-19 H12LP 4 5 8 3 936 5/27/2016 May-19 H12LP 4 5 8 6 615 5/27/2016 May-19 H12LP 4 5 8 5 685 6/1/2016 Jun-19 H12LP 4 5 8 9 373 6/1/2016 Jun-19 H12LP 4 5 8 9 677 6/1/2016 Jun-19 H12LP 4 5 9 0 455 6/1/2016 Jun-19 H12LP 4 5 8 9 665 6/3/2016 Jun-19 H12LP 4 5 9 6 066 6/3/2016 Jun-19 H12LP 4 5 9 0 464 6/6/2016 Jun-19 H12LP 4 5 9 3 587 6/6/2016 Jun-19 H12LP 4 5 9 4 649 6/6/2016 Jun-19 H12LP 4 5 9 8 005 6/6/2016 Jun-19 H12LP 4 6 0 0 043 6/6/2016 Jun-19 H12LP 4 6 0 2 957 6/6/2016 Jun-19 H12LP 4 6 0 3 588 6/6/2016 Jun-19 H12LP 4 6 0 3 590 6/6/2016 Jun-19 H12LP 4 5 9 7 997 6/8/2016 Jun-19 H12LP 4 5 9 8 476 6/8/2016 Jun-19 H12LP 4 6 0 7 573 6/8/2016 Jun-19 H12LP 4 6 0 8 496 6/8/2016 Jun-19 H12LP 4 6 0 8 514 6/8/2016 Jun-19 H12LP 4 6 0 9 747 6/8/2016 Jun-19 H12LP 4 6 1 0 175 6/8/2016 Jun-19 H12LP 4 6 1 0 839 6/8/2016 Jun-19 H12LP 4 6 1 1 167 6/8/2016 Jun-19 H12LP 4 6 1 1 179 6/8/2016 Jun-19 H12LP 4 6 1 2 670 6/8/2016 Jun-19 H12LP 4 6 1 0 894 6/10/2016 Jun-19 H12LP 4 6 1 3 359 6/10/2016 Jun-19 H12LP 4 6 1 3 889 6/10/2016 Jun-19 H12LP 4 6 1 4 603 6/10/2016 Jun-19 H12LP 4 6 1 4 912 6/10/2016 Jun-19 H12LP 4 6 1 5 536 6/10/2016 Jun-19 H12LP 4 6 1 8 135 6/10/2016 Jun-19 H12LP 4 6 1 5 246 6/13/2016 Jun-19 H12LP 4 6 1 6 746 6/15/2016 Jun-19 H12LP 4 6 5 8 690 6/29/2016 Jun-19 H12LP 4 6 5 9 478 7/1/2016 Jul-19 H12LP 4 6 5 9 552 7/1/2016 Jul-19 H12LP 4 6 5 9 568 7/1/2016 Jul-19 H12LP 4 6 6 0 191 7/1/2016 Jul-19 H12LP 4 6 6 2 392 7/1/2016 Jul-19 H12LP 4 6 6 2 668 7/1/2016 Jul-19 H12LP 4 6 6 3 276 7/1/2016 Jul-19 H12LP 4 6 6 4 081 7/1/2016 Jul-19 H12LP 4 6 6 4 364 7/5/2016 Jul-19 H12LP 4 6 6 6 763 7/5/2016 Jul-19 H12LP 4 6 6 8 273 7/5/2016 Jul-19 H12LP 4 6 7 2 293 7/5/2016 Jul-19 H12LP 4 6 6 7 846 7/7/2016 Jul-19 H12LP 4 6 6 9 208 7/7/2016 Jul-19 H12LP 4 6 7 0 712 7/7/2016 Jul-19 H12LP 4 6 7 1 055 7/7/2016 Jul-19 H12LP 4 6 6 8 287 7/11/2016 Jul-19 H12LP 4 6 7 0 139 7/11/2016 Jul-19 H12LP 4 6 7 2 065 7/11/2016 Jul-19 H12LP 4 6 7 2 678 7/11/2016 Jul-19 H12LP 4 6 7 3 558 7/11/2016 Jul-19 H12LP 4 6 7 4 512 7/11/2016 Jul-19 H12LP 4 6 7 4 857 7/11/2016 Jul-19 H12LP 4 6 7 2 303 7/12/2016 Jul-19 H12LP 4 6 7 6 800 7/12/2016 Jul-19 H12LP 4 6 8 0 853 7/12/2016 Jul-19 H12LP 4 6 8 1 245 7/12/2016 Jul-19 H12LP 4 6 8 2 434 7/12/2016 Jul-19 H12LP 4 6 6 8 260 7/14/2016 Jul-19 H12LP 4 6 7 8 568 7/14/2016 Jul-19 H12LP 4 6 8 0 352 7/14/2016 Jul-19 H12LP 4 6 8 0 368 7/14/2016 Jul-19 H12LP 4 6 8 1 485 7/14/2016 Jul-19 H12LP 4 6 8 3 268 7/14/2016 Jul-19 H12LP 4 6 8 3 954 7/14/2016 Jul-19 H12LP 4 6 8 4 773 7/14/2016 Jul-19 H12LP 4 6 8 4 917 7/14/2016 Jul-19 H12LP 4 6 8 3 949 7/18/2016 Jul-19 H12LP 4 6 8 4 955 7/18/2016 Jul-19 H12LP 4 6 8 6 200 7/18/2016 Jul-19 H12LP 4 6 8 6 942 7/18/2016 Jul-19 H12LP 4 6 9 4 457 7/18/2016 Jul-19 H12LP 4 5 1 8 669 7/19/2016 Jul-19 H12LP 4 6 8 8 031 7/20/2016 Jul-19 H12LP 4 6 8 8 326 7/20/2016 Jul-19 H12LP 4 6 8 8 887 7/20/2016 Jul-19 H12LP 4 6 8 8 894 7/20/2016 Jul-19 H12LP 4 6 9 0 786 7/20/2016 Jul-19 H12LP 4 6 9 5 707 7/20/2016 Jul-19 H12LP 4 6 9 3 611 7/22/2016 Jul-19 H12LP 4 6 9 5 036 7/22/2016 Jul-19 H12LP 4 6 9 9 014 7/22/2016 Jul-19 H12LP 4 0 7 4 165 7/25/2016 Jul-19 H12LP 4 6 9 3 329 7/25/2016 Jul-19 H12LP 4 6 9 6 019 7/25/2016 Jul-19 H12LP 4 6 9 7 608 7/25/2016 Jul-19 H12LP 4 6 9 8 746 7/25/2016 Jul-19 H12LP 4 7 0 1 597 7/25/2016 Jul-19 H12LP 4 6 9 9 424 7/27/2016 Jul-19 H12LP 4 7 0 0 514 7/27/2016 Jul-19 H12LP 4 7 0 0 522 7/27/2016 Jul-19 H12LP 4 7 0 4 395 7/27/2016 Jul-19 H12LP 4 7 0 4 437 7/27/2016 Jul-19 H12LP 4 7 0 5 381 7/27/2016 Jul-19 H12LP 4 7 0 8 776 7/27/2016 Jul-19 H12LP 4 7 1 1 866 7/28/2016 Jul-19 H12LP 4 7 1 5 840 7/28/2016 Jul-19 H12LP 4 7 2 6 685 7/29/2016 Jul-19 H12LP 4 7 3 0 128 7/29/2016 Jul-19 H12LP 4 7 3 1 690 7/29/2016 Jul-19 H12LP 4 7 4 1 142 7/29/2016 Jul-19 H12LP 4 7 4 0 540 8/1/2016 Aug-19 H12LP 4 7 4 1 157 8/1/2016 Aug-19 H12LP 4 7 4 4 985 8/1/2016 Aug-19 H12LP 4 7 4 5 359 8/1/2016 Aug-19 H12LP 4 7 4 5 889 8/1/2016 Aug-19 H12LP 4 7 4 6 386 8/1/2016 Aug-19 H12LP 4 7 4 9 418 8/1/2016 Aug-19 H12LP 4 7 4 9 402 8/3/2016 Aug-19 H12LP 4 7 5 0 299 8/3/2016 Aug-19 H12LP 4 7 5 1 118 8/3/2016 Aug-19 H12LP 4 7 5 3 896 8/5/2016 Aug-19 H12LP 4 7 5 3 906 8/5/2016 Aug-19 H12LP 4 7 5 7 161 8/5/2016 Aug-19 H12LP 4 7 6 0 422 8/5/2016 Aug-19 H12LP 4 7 6 2 156 8/8/2016 Aug-19 H12LP 4 7 6 6 617 8/8/2016 Aug-19 H12LP 4 7 6 6 751 8/8/2016 Aug-19 H12LP 4 7 4 8 478 8/9/2016 Aug-19 H12LP 4 7 7 2 854 8/11/2016 Aug-19 H12LP 4 7 7 6 931 8/11/2016 Aug-19 H12LP 4 7 7 7 716 8/11/2016 Aug-19 H12LP 4 7 8 6 543 8/12/2016 Aug-19 H12LP 4 7 8 9 098 8/12/2016 Aug-19 H12LP 4 7 9 3 711 8/15/2016 Aug-19 H12LP 4 7 9 9 173 8/17/2016 Aug-19
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.