CME America T-Syringe Pump - NeoThrive - Product Usage recall
CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at…
Why was CME America T-Syringe Pump - NeoThrive - Product Usage 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model NeoThrive - Part Number(s) 100-101PSL UDI Code: Retired prior to UDI
- Product
- CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at…
- Recalling firm
- CME America, LLC
- Quantity
- 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.
- Recall date
- December 9, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)