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CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring con...

FDA Device Recall #Z-0525-2021 — Class II — July 30, 2020

Recall Summary

Recall Number Z-0525-2021
Classification Class II — Moderate risk
Date Initiated July 30, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CME America, LLC
Location Golden, CO
Product Type Devices
Quantity Total Pumps = 4,182 (all models)

Product Description

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).

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.

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.

Lot / 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

Other Recalls from CME America, LLC

Recall # Classification Product Date
Z-0530-2021 Class II CME America T-Syringe Pump - T34 - Product Usag... Jul 30, 2020
Z-0529-2021 Class II CME America T-Syringe Pump - Ameritus 1st Enter... Jul 30, 2020
Z-0528-2021 Class II CME America T-Syringe Pump - Neofeed - Product ... Jul 30, 2020
Z-0527-2021 Class II CME America T-Syringe Pump - T34L PCA - Product... Jul 30, 2020
Z-0526-2021 Class II CME America T-Syringe Pump - NeoThrive - Produc... Jul 30, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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