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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-0525-2021
Recall Event ID 86047
510(K)Number K080954  
Product Classification Pump, infusion - Product Code FRN
Product CME America T-Syringe Pump -T34L - 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 TR34L - Part Number(s) 100-100PSLA; 100-101PSLA Serial Number: 58766 58765 26479 69547 69548 26428 26299 26301 26295 26294 26304 26296 26298 26302 26297 26300 26130 26133 26132 58906 58907 58909 58910 58911 58912 58913 58914 58915 58916 58917 58918 58919 58920 58921 58922 58923 58924 58925 58926 58998 59003 59007 58999 59006 59000 59004 59002 59005 59001 69618 69619 69628 69629 69630 69637 69659 69666 69638 69579 70119 70134 70136 70142 70144 70145 70146 70147 70148 70162 70167 70169 70172 70173 70174 70175 70143 S25610 S25720 S25725 S25729 S69776 S69785 S70157 S70160 S70165 S70176 S70192 S70203 S70206 S70207 S70208 S70209 S70210 S70211 S70129 S70177 S70181 S70205 S70114 S70115 S70117 S70118 S70120 S70121 S70124 S70125 S70126 S70127 S70128 S70130 S70131 S70132 S70138 S70139 S70140 S70163 S70164 S70166 S70182 S70183 S70185 S70187 S70188 S70190 S70191 S70194 S70195 S70196 A12200 A12201 S69760 A100795 A100796 A100797 A100798 A100799 A100800 A100801 A100802 A100803   UDI Code: B101100100PSLA0 100-101 PSLA was 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 2		 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 and Original Applicant = CAESAREA MEDICAL ELECTRONICS LTD.
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