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U.S. Department of Health and Human Services

Class 2 Device Recall CME America TSyringe Pump

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  Class 2 Device Recall CME America TSyringe Pump see related information
Date Initiated by Firm July 30, 2020
Create Date December 03, 2020
Recall Status1 Terminated 3 on March 08, 2022
Recall Number Z-0530-2021
Recall Event ID 86047
510(K)Number K080954  
Product Classification Pump, infusion - Product Code FRN
Product CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
Code Information Model T34 - Part Number(s) 100-100PS; 100-100PSA; 100-100POBSC; 100-101PS Serial Number: 58771 58772 58773 58774 58775 58776 58777 58778 58779 58780 58781 58782 58783 58784 58785 58786 58787 58788 58789 58790 26478 S26442 S26443 S26444 26305 26307 26309 26310 26311 26312 26313 26314 26315 26316 26317 26318 26319 26320 26321 26322 26335 26323 26324 26325 26326 26327 26328 26329 26330 26331 26332 26333 26334 26336 26337 26338 26339 26340 26341 26342 26343 26344 26345 26346 26347 26348 26349 26350 26351 26352 26353 26354 26355 26356 26357 26358 26360 26361 26362 26363 26364 26365 26366 26367 26368 26369 26370 26371 26372 26373 26374 26375 26376 26377 26378 26379 26380 26381 26382 26383 26384 26386 26387 26388 26389 26390 26391 26392 26393 26394 26395 26396 26397 26398 26399 26400 26401 26402 26404 26405 26407 26408 S26261 S26262 S26263 S26264 S26265 S26266 26139 26140 26137 26141 26138 26146 26142 26144 26145 26143 26147 26151 26148 26149 26150 25923 25924 25925 25926 25927 82572 82580 A100488 A100526 A100527 A100514 A100493 A100535 A100531 A100519 A100505 A100492 A100496 A100490 A100501 A100522 A100524 A100513 A100529 A100528 A100533 A100518 A100507 A100497 A100495 A100500 A100503 A100489 A100523 A100515 A100512 A100537 A100530 A100534 A100521 A100510 A100498 A100509 A100499 A100504 A100525 A100516 A100511 A100536 A100532 A100517 A100520 A100508 A100506 A100491 A100502 A100494 A100152 A100153 A100154 A100155 58852 58854 58855 58856 58857 58858 58860 58861 58862 58863 58864 58865 58866 58867 58868 58869 58870 58871 58872 58873 58874 58875 58876 58877 58878 58880 58882 58883 58885 58886 58887 58888 58889 58890 58891 58892 58893 58895 58896 58897 58898 58899 58900 58901 58902 58903 58904 58945 58946 58947 58948 58949 58950 58952 58953 58954 58955 58957 58958 58959 58960 58962 58963 58964 58965 58966 58967 58968 58969 58970 58971 58972 58973 58974 58975 58976 58977 58978 58979 58980 58981 58982 58983 58984 58985 58986 58987 58988 58989 58990 58991 58993 58994 58995 69596 69598 69613 S69884 S69885 S69886 S69887 S69888 S69889 S69890 S69891 S69892 S69893 S69894 S69895 S69896 S69897 S69898 S69899 S69900 S69901 S69902 S69903 S69904 S69905 S69906 S69908 S69909 S69910 S69911 S69912 S69913 S69914 S69915 S69916 S69917 S69918 S69919 S69920 S69922 S69923 S69925 S69926 S69927 S69928 S69929 S69930 S69931 S69932 S69934 S69935 S79589 S79590 S69723 S69725 S69726 S69729 S69730 S69732 S69733 S69735 S69738 S69740 S90001 S90002 S90003 S90004 S90000 S90005 S90006 S70020 S70021 S70022 S70023 S70024 S70025 S70026 S70027 S70028 S70029 S70030 S70031 S70032 S70033 S70034 S70035 S70036 S70037 S70038 S70039 S70040 S70041 S70042 S70043 S70044 S70045 S70046 S70047 S70048 S70050 S70051 S70052 S70053 S70054 S70055 S70056 S70057 S70058 S70059 S70060 S70061 S70062 S70063 S70064 S70069 S70072 S70074 S70075 S70079 S70080 A100001 A100002 A100003 A100004 A100005 A100006 A100007 A100008 A100009 A100010 A100011 A100012 A100013 A100014 A100015 A100016 A100017 A100018 A100019 A100020 A100021 A100022 A100023 A100024 A100025 A100026 A100027 A100028 A100029 A100030 A100031 A100032 A100033 A100034 A100035 A100036 A100037 A100038 A100039 A100040 A100041 A100042 A100043 A100044 A100045 A100046 A100047 A100048 A100049 A100050 A100051 A100052 A100053 A100054 A100055 A100056 A100057 A100058 A100059 A100060 A100061 A100062 A100063 A100064 A100065 A100066 A100067 A100068 A100069 A100070 A100071 A100072 A100073 A100074 A100075 A100076 A100077 A100078 A100079 A100080 A100081 A100082 A100083 A100084 A100085 A100086 A100087 A100088 A100089 A100090 A100091 A100092 A100093 A100094 A100095 A100096 A100097 A100098 A100099 A100100 S69737 A100102 A100103 A100104 A100105 A100106 A100107 A100108 A100109 A100110 A100111 A100112 A100113 A100114 A100119 A100120 A100121 A100122 A100123 A100124 A100125 A100126 A100127 A100128 A100130 A100131 A100132 A100133 A100134 A100135 A100136 A100137 A100140 A100141 A100142 A100143 A100144 A100145 A100147 A100150 A100151 A100139 A100115 A100116 A100117 A100129 A100138 A100146 A100148 A100149 A100159 A100161 A100162 A100163 A100164 A100165 A100166 A100167 A100168 A100169 A100170 A100171 A100172 A100173 A100174 A100175 A100176 A100177 A100178 A100179 A100180 A100181 A100183 A100184 A100185 A100186 A100188 A100189 A100190 A100191 A100192 A100193 A100194 A100195 A100197 A100198 A100199 A100200 A100201 A100202 A100203 A100204 A100207 A100209 A100210 A100211 A100212 A100214 A100225 A100226 A100227 A100228 A100229 A100238 A100239 A100283 A100286 A100289 A100290 A100291 A100292 A100205 A100213 A100219 A100221 A100222 A100223 A100224 A100280 A100284 A100206 A100208 A100217 A100218 A100220 A100240 A100241 A100242 A100243 A100244 A100245 A100246 A100247 A100248 A100249 A100250 A100251 A100252 A100253 A100254 A100255 A100256 A100257 A100258 A100259 A100260 A100261 A100262 A100263 A100264 A100265 A100266 A100267 A100268 A100269 A100270 A100271 A100272 A100273 A100274 A100275 A100276 A100277 A100278 A100279 A100281 A100282 A100285 A100287 A100288 A100160 A100182 A100187 A100196 A100215 A100216 A100230 A100231 A100232 A100233 A100234 A100235 A100236 A100237 A100299 A100300 A100301 A100302 A100303 A100304 A100305 A100306 A100307 A100308 A100309 A100310 A100311 A100312 A100313 A100315 A100316 A100317 A100318 A100319 A100320 A100321 A100322 A100323 A100324 A100325 A100326 A100327 A100328 A100329 A100330 A100332 A100333 A100334 A100335 A100336 A100337 A100338 A100339 A100341 A100344 A100345 A100346 A100347 A100348 A100349 A100351 A100352 A100353 A100354 A100355 A100356 A100357 A100358 A100359 A100360 A100361 A100362 A100363 A100365 A100366 A100367 A100368 A100369 A100370 A100371 A100372 A100374 A100375 A100376 A100377 A100378 A100379 A100380 A100381 A100383 A100384 A100385 A100386 A100387 A100388 A100389 A100390 A100391 A100392 A100393 A100394 A100395 A100396 A100397 A100398 A100399 A100400 A100401 A100402 A100403 A100404 A100405 A100406 A100407 A100408 A100409 A100410 A100411 A100412 A100413 A100414 A100415 A100416 A100417 A100418 A100419 A100420 A100421 A100422 A100423 A100424 A100425 A100426 A100427 A100428 A100429 A100430 A100431 A100432 A100433 A100373 A100364 A100434 A100435 A100436 A100437 A100438 A100439 A100440 A100441 A100442 A100443 A100444 A100445 A100446 A100447 A100448 A100449 A100450 A100451 A100452 A100453 A100454 A100455 A100456 A100457 A100458 A100459 A100460 A100461 A100462 A100463 A100464 A100465 A100466 A100467 A100468 A100469 A100470 A100471 A100472 A100473 A100474 A100475 A100476 A100477 A100478 A100479 A100480 A100481 A100482 A100483 A100118 A100293 A100298 A100314 A100331 A100340 A100342 A100343 A100350 A100382 A100294 A100295 A100296 A100484 A100485 A100486 A100487 A100538 A100539 A100540 A100541 A100542 A100543 A100544 A100545 A100546 A100547 A100548 A100549 A100550 A100551 A100552 A100554 A100555 A100556 A100557 A100562 A100564 A100565 A100566 A100567 A100568 A100569 A100570 A100571 A100572 A100573 A100574 A100575 A100576 A100577 A100578 A100579 A100580 A100581 A100582 A100583 A100584 A100586 A100587 A100588 A100589 A100590 A100591 A100594 A100595 A100596 A100597 A100598 A100599 A100600 A100601 A100602 A100603 A100604 A100605 A100606 A100607 A100608 A100609 A100610 A100611 A100614 A100615 A100616 A100617 A100618 A100619 A100620 A100621 A100622 A100623 A100624 A100625 A100626 A100627 A100628 A100629 A100630 A100631 A100632 A100553 A100633 A100634 A100635 A100636 A100637 A100638 A100639 A100640 A100641 A100642 A100643 A100644 A100645 A100646 A100647 A100648 A100659 A100663 A100664 A100665 A100666 A100672 A100673 A100676 A100677 A100679 A100680 A100681 A100682 A100683 A100684 A100685 A100686 A100687 A100688 A100690 A100691 A100692 A100693 A100702 A100734 A100735 A100736 A100737 A100738 A100739 A100740 A100741 A100742 A100743 A100744 A100745 A100746 A100747 A100748 A100749 A100750 A100751 A100752 A100753 A100754 A100755 A100756 A100757 A100758 A100759 A100760 A100761 A100762 A100763 A100764 A100765 A100766 A100767 A100768 A100770 A100771 A100772 A100773 A100774 A100775 A100776 A100777 A100778 A100779 A100780 A100781 A100782 A100783 A100784 A100785 A100786 A100787 A100788 A100789 A100790 A100791 A100792 A100793 A100726 A100720 A100649 A100650 A100651 A100652 A100654 A100655 A100656 A100657 A100658 A100660 A100661 A100662 A100667 A100668 A100669 A100670 A100558 A100559 A100560 A100561 A100563 A100585 A100592 A100593 A100612 A100613 A100804 A100805 A100806 A100807 A100808 A100809 A100810 A100811 A100812 A100813 A100814 A100815 A100816 A100817 A100818 A100819 A100820 A100821 A100822 A100823 A100824 A100825 A100826 A100827 A100828 A100829 A100830 A100831 A100832 A100833 A100834 A100835 A100836 A100837 A100838 A100839 A100840 A100841 A100842 A100843 A100671 A100674 A100675 A100678 A100689 A100694 A100711 A100719 A100725 A100727 A100732 A100695 A100696 A100697 A100698 A100699 A100700 A100701 A100703 A100844 A100845 A100846 A100847 A100848 A100849 A100850 A100851 A100852 A100853 A100854 A100855 A100856 A100857 A100858 A100859 A100860 A100861 A100862 A100863 A100864 A100865 A100866 A100867 A100868 A100869 A100870 A100871 A100872 A100873 A100874 A100875 A100876 A100877 A100878 A100879 A100880 A100881 A100882 A100883 A100884 A100885 A100886 A100887 A100888 A100889 A100890 A100891 A100892 A100893 A100894 A100895 A100896 A100897 A100898 A100899 A100900 A100901 A100903 A100904 A100905 A100906 A100907 A100908 A100909 A100910 A100911 A100912 A100913 A100914 A100915 A100916 A100917 A100918 A100919 A100920 A100921 A100922 A100923 A100924 A100925 A100926 A100927 A100928 A100929 A100930 A100931 A100932 A100933 A100934 A100935 A100936 A100937 A100938 A100939 A100940 A100941 A100942 A100943 A100944 A100945 A100946 A100947 A100948 A100949 A100950 A100951 A100952  UDI Codes: B101100100POBSC0 B101100100PSA0 100-100PS and 100-101PS retired prior to UDI 
Recalling Firm/
CME America, LLC
14998 W 6th Ave Ste 830
Golden CO 80401-5025
For Additional Information Contact Customer/Technical Support
Manufacturer Reason
for Recall
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
FDA Determined
Cause 2
Action On July 30, 2020, the firm sent an "URGENT MEDICAL DEVICE RECALL CORRECTION" Notification Letter via FedEx to customers informing them of two issues: Issue 1: The motor block mechanism may be affected over time by normal wear and tear which may cause the device to stop without alarms being generated. Issue 2: Due to routine cleaning and disinfection, there is a potential for fluid to ingress into the pump and over time, could result in damage to the pump components leading to inoperability of the device. For this issue the device will stop and will alarm. The Recalling Firm is instructing customers to: For Issue 1: Inspect the lead screw to detect the presence of white plastic debris. Inspection must be performed prior to each use of the affected pumps. If signs of wear and tear are observed, discontinue use of the pump and contact the Recalling Firm for product removal. For Issue 2: Follow the Manufacturer Recommended Cleaning instructions in Appendix A and the Technical Service Manual instructions for preventive maintenance provided in Appendix B of the attached Customer Letter to limit the cumulative effects of fluid ingress over time. Immediate Actions to Take: 1) Please refer to the attached customer communication regarding this recall action. 2) As the Recalling Firm plans to notify all affected customers directly, customers are asked to identify customers within their distribution network that purchased the affected product, as defined in the recall notification. Email an excel file listing of all customers to BDRC12@bd.com within 72 hours of receipt of this letter so that the Recalling Firm may initiate customer notification. 3) Complete the attached Distributor Response Form and return to the Recalling Firm's contact noted on the form whether or not the customers have any of the impacted material so that the Recalling Firm may acknowledge the receipt of this notification. 4) Contact the Recalling Firm to arrange for the return of all in sto
Quantity in Commerce Total pumps = 4,182 (all models)
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FRN and Original Applicant = CAESAREA MEDICAL ELECTRONICS LTD.