Class 2 Device Recall CME America TSyringe Pump

• Date Initiated by Firm: July 30, 2020
• Create Date: December 03, 2020
• Recall Status: Terminated 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 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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/ Manufacturer: CME America, LLC; 14998 W 6th Ave Ste 830; Golden CO 80401-5025
• For Additional Information Contact: Customer/Technical Support; 303-936-4945
• 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: Other
• 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