21

Apr

2004

Inc Class III Medex

infusionpump, recall

0

Company: Medex, Inc.
Date of Enforcement Report: 4/21/04
Class: III

PRODUCT
Medex 3000 Series Syringe Infusion Pumps.
Recall # Z-0813-04.

CODE
Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump for use with 1cc to 60cc syringes), 3010aZE (Refurbished pump for use with 1cc to 60cc syringes), 3010E (Pump for use with 3-60cc used in the UK), 3010SD (Model 3010 pump used for demonstrations), 3010VX (Evaluation pump for use with 3-60cc syringes), 3010E, 3500 (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits), 3500BC (Not currently in distribution, 3500E (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits used I the UK), 3500G (Pump with face plates and software for rapid occlusion detection and upper and lower programmable infusion dose limits in the German language), 3500SD (Model 3500 pump used for demonstrations, 3500VX (Evaluation pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits.

RECALLING FIRM/MANUFACTURER
Medex, Inc., Duluth, GA, by letter starting on February 2, 2004. Firm initiated recall is ongoing.

REASON
Inadequate warning label: It is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.

VOLUME OF PRODUCT IN COMMERCE
7,896 units.

DISTRIBUTION
Nationwide, China, Hong Kong & UK.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.

Registration Link:

TBD

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD