Z-0526-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- July 30, 2020
- Termination Date
- March 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total pumps = 4,182 (all models)
Product Description
CME America T-Syringe Pump - NeoThrive - 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.
Code Information
Model NeoThrive - Part Number(s) 100-101PSL UDI Code: Retired prior to UDI