Reported Dec 9, 2020 · Terminated
CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or…
CME America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CME America, LLC · 14998 W 6th Ave Ste 830 · Golden, CO · 80401-5025
Is this the product you have?
- CME America
- T-Syringe Pump -T34L - Product Usageinfusion 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)
- Lot codes and dates
Model TR34L - Part Number(s) 100-100PSLA100-101PSLA
- Serial Number
137 of 137 codes
587665876526479695476954826428262992630126295262942630426296262982630226297263002613026133261325890658907589095891058911589125891358914589155891658917589185891958920589215892258923589245892558926589985900359007589995900659000590045900259005590016961869619696286962969630696376965969666696386957970119
- A100801 A100802 A100803 UDI CodeB101100100PSLA0 100-101 PSLA was retired prior to UDI
- Amount recalled
- Total Pumps = 4,182 (all models)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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