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-0529-2021
• Recall Event ID: 86047
• 510(K)Number: K080954
• Product Classification: Pump, infusion - Product Code FRN
• Product: CME America T-Syringe Pump - Ameritus 1st Enteral Pump - 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 Ameritus 1st Enteral Pump - Part Number(s) AEG-1PUMP Serial Number: 58791 58770 58769 58768 58760 26417 26480 26481 26482 26483 26466 26467 26468 26469 26470 26471 26472 26473 26474 26475 26476 26477 26453 26454 26457 26448 26452 26449 26458 26455 26451 26459 26450 26445 26446 26440 26441 26427 26419 26420 26421 26422 26423 26424 26425 26426 26411 26413 26414 26416 26283 26284 26285 26286 26287 26288 26289 26290 26291 26292 26293 26281 26282 26252 26255 26254 26257 26250 26251 26256 26253 26249 26248 26267 26242 26243 26244 26245 26246 26247 26212 26215 26216 26217 26218 26219 26220 26221 26222 26223 26224 26225 26226 26227 26228 26229 26230 26231 26232 26233 26234 26235 26236 26237 26238 26239 26240 26162 26165 26166 26167 26169 26170 26172 26175 26176 26177 26180 26181 26182 26183 26184 26186 26163 26164 26168 26171 26173 26174 26178 26179 26185 26095 26100 26098 26062 26102 26109 26101 26069 26067 26020 26018 26019 26064 26093 26085 26099 26096 26097 26094 26090 26089 26092 26086 26111 26106 26060 26066 26063 26059 26065 26123 26119 26076 26083 26121 26080 26079 26078 26091 26105 26104 26103 26108 26112 26122 26126 26118 26082 26127 26072 26113 26107 26114 26110 26071 26081 26117 26075 26116 26073 26115 26074 26070 26120 26125 26026 26032 26029 26030 26027 26021 58811 58813 58814 58815 58816 58817 58818 58819 58821 58822 58823 58826 58827 58830 58927 58928 58929 58930 58931 58932 69790 69791 69792 69793 69794 69795 69796 69797 69798 69800 69802 69803 69805 69806 69807 69808 69809 69810 69811 69812 69813 69814 69874 69875 69876 69878 69879 69881 69882 A100156 A100157 A100158 S69877 S69880 S69883 S70112 S70122 S70123 S70133 S70135 S70137 S70156 S70171 S70179 S70180 S70197 S70199 S70200 S70201 UDI Code: B101AEG1PUMP0
• 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