{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "182566", "product_res_number": "Z-0527-2021", "event_date_initiated": "2020-07-30", "event_date_created": "2020-12-03", "recall_status": "Terminated", "event_date_terminated": "2022-03-08", "res_event_number": "86047", "product_code": "FRN", "k_numbers": [ "K080954" ], "product_description": "CME America T-Syringe Pump - T34L PCA - 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_info": "Model T34L PCA - Part Number(s) (UDI Codes) 100-106PSL (UDI Code: B101100106PSL0) Serial Number: 26486 26485 26484 S93716  100-106PSLM (retired prior to UDI)", "firm_fei_number": "3006967710", "recalling_firm": "CME America, LLC", "address_1": "14998 W 6th Ave Ste 830 14998 W 6th Ave", "address_2": "Ste 830", "city": "Golden", "state": "CO", "postal_code": "80401-5025", "additional_info_contact": "Customer/Technical Support\n303-936-4945", "reason_for_recall": "Multiple reasons:\n1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated.\n2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.", "root_cause_description": "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:\nIssue 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.\nIssue 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.\n\nThe Recalling Firm is instructing customers to:\nFor 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.\nFor 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.\n\nImmediate Actions to Take:\n1) Please refer to the attached customer communication regarding this recall action.\n2) 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.\n3) 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.\n4) Contact the Recalling Firm to arrange for the return of all in sto", "product_quantity": "Total pumps = 4,182 (all models)", "distribution_pattern": "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.", "openfda": { "k_number": [ "K841827", "K811739", "K941595", "K812442", "K933144", "K042121", "K832923", "K990425", "K882249", "K882047", "K882556", "K941984", "K051568", "K010566", "K803190", "K830544", "K895709", "K844915", "K812499", "K211122", "K161469", "K801904", "K980378", "K910024", "K910919", "K920588", "K905610", "K031600", "K842421", "K944190", "K101194", "K912590", "K863864", "K890457", "K904924", "K803183", "K843615", "K844768", "K003616", "K912589", "K830017", "K873495", "K222048", "K920013", "K091042", "K830809", "K895797", "K982159", "K994375", "K831935", "K041714", "K073051", "K914854", "K850098", "K881759", "K872850", "K900375", "K242390", "K953382", "K183311", "K903786", "K843949", "K012044", "K241736", "K972284", "K892906", "K854318", "K832641", "K852073", "K844718", "K931458", "K860162", "K932847", "K832755", "K231918", "K914855", "K091855", "K822454", "K022869", "K882594", "K870801", "K072105", "K893769", "K903571", "K870279", "K853664", 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"3003058448", "3010293992", "3007939342", "3003098013", "3024122953", "3036773433", "1000136269", "1220973", "3016798778", "3003767881", "3000206435", "2521402", "3010273872", "3014732157", "1219602", "3002808022", "3004056159", "3004082685", "1000117172", "3004167615", "3004530184", "3015192982", "2648209", "1643817", "3006534321", "3010291427" ], "device_name": "Pump, Infusion", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ] }