FDAFDA · Food and drugs·Recall number Z-0527-2021
CME America T-Syringe Pump - T34L PCA - 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).
Published December 9, 2020 · Recall initiated: July 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CME America, LLC
- Distributor
- 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
- Model T34L PCA - Part Number(s) (UDI Codes) 100-106PSL (UDI Code: B101100106PSL0) Serial Number: 26486 26485 26484 S93716 100-106PSLM (retired prior to UDI)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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