FDAFDA · Food and drugs·Recall number Z-0530-2021
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).
Published December 9, 2020 · Recall initiated: July 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CME America, LLC
- Distributor
- 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.
- Lot
- 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 A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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