FDA Issues Safety Communication About Philips Recall - Sleep Review

• California Exemptee License Training Certification Course - Buy Now!
  For home medical device retailers (HMDR). 
• FDA GMP online training courses offered by SkillsPlus International Inc.

According to the article:

"The US Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021."

Read the full source article:  FDA Issues Safety Communication About Philips Recall - Sleep Review

Related news:

• PHILIPS ISSUES RECALL - HME News
• PHILIPS RECALL: AASM CALLS FOR SUPPORT FROM CMS, PAYERS

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Recall: Bed handle linked to 3 deaths | Ruth To The Rescue - Home

Read the article for full details: Recall: Bed handle linked to 3 deaths | Ruth To The Rescue - Home - Click On Detroit:

"They were sold by home health care stores, drug stores and medical equipment stores nationwide and in home and health care catalogs from January 1994 through December 2007 for about $100. They were manufactured in the United States.

What To Do 

Consumers should immediately stop using all recalled bed handles that were sold without safety retention straps. Contact Bed Handles, Inc. for free safety retention straps to secure the bed handle to the bed frame, new assembly and installation instructions for models BA10W, BA11W and AJ1 and a warning label to attach to the bed handles. The bed handles should be used only with the safety retention straps securely in place attaching the bed handle to the bed frame in order to prevent a gap.

Contact Bed Handles Inc. at 800-725-6903 from 8:30 a.m. to 4:30 p.m. CT Monday through Friday,"

'via Blog this'

For more information:  Bed Handles, Inc. safety recall webpage

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

FDA Orders Baxter Colleague Pump Refunds and Replacements

The FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall - Company must provide transition guide for facilities using Colleague infusion pumps.
 
In brief, in a Colleague Pump - Consent Decree letter to two Baxter executives, the FDA orders Baxter to take the following actions:

• Recall and destroy all Colleague infusion pumps covered by the Consent Decree that are manufactured, distributed, or sold by Baxter or that are under the custody and control of Baxter's agents, distributors, or customers from the US market..
• Provide either a replacement infusion pump (other than the Colleague model) or refund to all owners, and a lease termination to all lessees, of Colleague infusion pumps no later than the date that is twenty four months after the date of this final order (“the transition period”).

Return Home:  The Designated Representative and Exemptee Blog

FDA Orders Recall and Destruction of Baxter Colleague Infusion Pumps

• The top choice in Exemptee training. Enroll now to take California HMDR Exemptee training certification.

Updated July 5, 2026

The links broke.

You can still read about this topic here:

FDA Issues Requirements for Baxter International, Inc. Infusion Pump Recall - Biospace

You might also like:
Infusion Pumps - FDA.gov:
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/infusion-pumps

- -  original post follows below  - -

Uh-oh. The FDA believes there may be as many as 200,000 of these pumps currently in use. And they want them recalled and destroyed, as announced in FDA Issues Statement on Baxter’s Recall of Colleague Infusion Pumps.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction.

If you have questions about what this might mean for you, then read this, FDA - Questions and Answers About the Baxter Colleague Recall, Refund, and Replacement Action.

Return Home:  The Designated Representative and Exemptee Blog

- - -

Training for HMDR Exemptee license applicants

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute