The U.S. Food and Drug Administration (FDA) has jurisdiction over a wide variety of medical devices and drugs. Endotracheal tubes (ETT) are some such medical devices that are used for opening a patient’s airway, providing ventilation, and administering anesthesia during an operation. One manufacturer of these ETTs, Teleflex has become the target of a recall on their ETTs in recent weeks. The FDA Teleflex Recall affects millions of devices across the nation and threatens the safety of millions of Americans.
Explaining The FDA Teleflex Recall
ETTs are used when a patient cannot breathe on their own and are especially useful in surgical procedures that use inhaled anesthetic gases to subdue patients. With such a vital role in surgeries, their manufacturing and deployment must be of the highest quality to ensure nothing goes wrong. Unfortunately, errors are made.
The FDA Teleflex recall is a Class I recall. This is the most serious caliber of recall, reserved only for drugs and devices that stand a substantial chance of causing serious injuries or death from their continued use. According to the FDA Teleflex recall announcement, 6,067,502 Teleflex products distributed during the two-and-a-half year period between October 2016 and May 2019 may fall into this category.
The FDA Teleflex recall was initiated by Teleflex on May 22, 2019. The recall was issued in response to complaints that the Sheridan series connector was disconnecting from the breathing circuit of ventilator machines. By design, each endotracheal tube features a 15mm connector to secure the connection between the tubes and their respective breathing devices. The issue that sparked the FDA Teleflex recall was that the tubes were disconnecting too easily. In order for the connection to be safe, the Sheridan series was designed in a way that they should not disconnect from the endotracheal tube without significant force.
According to the announcement released with the FDA Teleflex recall, disconnection from the breathing unit may result in insufficient oxygenation, suffocation, and death. Teleflex Medical disclosed to the FDA that it had received 179 complaints with 192 occurrences off ETT disconnection. This has also led to two confirmed deaths and one injury. Following this announcement, the FDA Teleflex recall was announced.
The products affected by the FDA Teleflex recall include:
- Hudson RCI® Sheridan LTS®
- Hudson RCI® Sheridan (CF, Preformed, HZT) 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm
- Hudson RCI® Sheridan®/EZ-ENDO 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm
- Hudson RCI® Sheridan® Uncuffed 6.0, 6.5, 7.0 mm
- Sheridan/CF Novaplus® 7.0
- Sheridan/HVT® Novaplus® 7.0, 7.5, 8.0, 8.5 mm
On May 24, 2019, Teleflex Medical issued an Urgent Recall Notification to its buyers, instructing customers to inspect their inventories for the affected product codes. Any buyers with affected products in inventory were asked to, immediately discontinue use and quarantine the products. Buyers were also called to notify Teleflex of the product so they could return the damaged devices.
For more information about dangerous medical devices, see Parker Waichman’s in-depth coverage of faulty devices on their Defective Medical Device Page.
How The FDA Teleflex Recall Affects Claimants
The FDA Teleflex recall showcases how the industry is imperfect. Whether through innocent oversight or lack of rigorous product testing, more than six million defective products were distributed from 2016 to 2019. Though the damage is now being called back and undone, almost 200 victims have already suffered perils, injuries, and deaths at the hands of an unsafe product. If you or a loved one have had medical complications after an endotracheal tube came loose during a procedure, don’t hesitate to pursue your claim. Call the most qualified lawyers to represent you. Call Parker Waichman LLP.
At Parker Waichman LLP, teams of product liability trial attorneys are prepared and experienced in the laws and regulations necessary to pursue your claim to its furthest conclusion to earn you the compensation you need to pay medical bills, funeral costs, or simply supplement your income while out on medical leave. If you want justice don’t wait. Contact Parker Waichman today for a free consultation.