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Reprocessed Xcel Bladeless Trocar (H12LP) recallZ-0765-2017 · Stryker Sustainability Solutions · initiated Nov 11, 2016

Class II Terminated All recalls posted in December 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.

FDA root cause category: No Marketing Application

What the company is doing

Stryker sent an Urgent Medical Device Recall letter to all affected customers on November 11, 2016. Customers were instructed to discontinue use of the affected lots and were asked to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices from the lots referenced in Attachment 1 remain in their inventory. This form must be completed even if no affected product is found. www.novasyte.com/sss142 Use the following reference number as you complete the form: [Ship to Account #]. If the form indicates that any affected devices remain in your inventory, a prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to your facility. Address any questions regarding the recall to Novasyte by calling (760) 279-3180 or emailing [email protected].

Recall details

Recall number
Z-0765-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 11, 2016
Posted by the FDA
Dec 14, 2016
Recalling firm
Stryker Sustainability Solutions
Quantity
40,476 devices
Product code
NLM
FDA submissions
K062497
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA

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.

Code information (models, lots, serial numbers)

Show the full code information (16k characters)

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

Other devices under the same FDA submission

1 device cleared under K062497 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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