Parker Waichman LLP

ConchaSmart Breathing Circuit Device Recall

UNITED STATES – As reported in an online news article published by www.pulmonologyadvisor.com and according to an FDA public health notification, Teleflex, a medical device manufacturer, has recalled its Neonatal ConchaSmart Breathing Circuit following reports of cracking on the swivel wye adapters, posing a risk of harm to patients. Teleflex’s Neonatal ConchaSmart Breathing Circuit device is […]

Teleflex Issues Recall of Neonatal ConchaSmart Breathing Circuit Device

Breathing circuit device recall

UNITED STATES – As reported in an online news article published by www.pulmonologyadvisor.com and according to an FDA public health notification, Teleflex, a medical device manufacturer, has recalled its Neonatal ConchaSmart Breathing Circuit following reports of cracking on the swivel wye adapters, posing a risk of harm to patients.

Teleflex’s Neonatal ConchaSmart Breathing Circuit device is used with neonatal and infant patients who require mechanical ventilation, positive pressure breathing assistance, and general medical gasses.  The ConchaSmart provides a “channel” for breathing gas between a patient and a ventilator.  The ConchaSmart includes heated wires used with the Hudson RCI Neptune Heated Humidifier. The heated wires are used to assist in maintaining a set temperature for a patient and to minimize condensation in the ventilator tubing.

According to the United States Food and Drug Administration (FDA), Teleflex has recalled a total of 300 devices distributed in the United States with product codes 870-07KIT and 870-09KIT, and lot numbers 74L1802044 and 74L1802045.  The affected lots were manufactured in November 2018 and distributed between December 2018 and January 2019.

Teleflex recalled the 300 Neonatal ConchaSmart Breathing Circuits following reports of cracking on the swivel wye adapters.  Teleflex received a total of two complaints of cracking, which were observed on the devices before use.  Such cracking can lead to breathing distress as gas can leak and not reach the patient. Insufficient oxygen could lead to severe injuries, such as brain damage, and death.  Teleflex reports that no injuries or deaths have been reported, but that 30% of adapters are expected to have cracking.

Hospitals and healthcare professionals are instructed to immediately discontinue using the Neonatal ConchaSmart Breathing Circuit devices and quarantine all devices in their inventory.  Hospitals and healthcare providers are also instructed to complete an Acknowledgment Form stating whether they have any of the affected ConchaSmart products in their possession.

[sc name=”post-footers”]

[contact_js_widget content=”Has your baby been harmed by a defective Teleflex Neonatal ConchaSmart Breathing Circuit device?” button=”Click To Get A Free Case Review” link=”/contact-new-york/”]

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value Tina Morace is extremely reliable, responsive, knowledgeable, accessible and has excellent customer service skills! She is true professional and an asset to Parker Waichman LLP. I highly recommend Tina!
Laura Kelley
3 years ago
5 Star Reviews 150
I highly recommend Parker Waichman. Their staff Ashley, Jorge and Gina are very professional. I was really happy with their service.
Tonia Bailey
4 years ago
5 Star Reviews 150
I originally met Joanne Stevens at an orthopedic office. After hearing my story she got in contact with me, and recommended I get in contact with Parker waichman where she works, and got me involved in a class action suit She has kept up communications and has answered all the questions I've had during this process.
Jim Langille
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038