Recall Z-0528-2021— CME America, LLC

Name: FDA recall Z-0528-2021
Creator: U.S. Food and Drug Administration
Published: 2020-07-30

Class II · Terminated

Class II FDA medical device recall by CME America, LLC, initiated 2020-07-30, terminated 2022-03-08. It names one FDA 510(k) clearance: K080954. Product: CME America T-Syringe Pump - Neofeed - 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: 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..

Recalling firm: CME America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Terminated: 2022-03-08
Firm location: Golden, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K080954 — T34L SYRINGE DRIVERCaesarea Medical Electronics , Ltd.·cleared 2008-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CME America T-Syringe Pump - Neofeed - 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.