Teleflex COMFORT FLO System's Voluntary Recall Ranked Class I
Zacks Investment Research | Feb 16, 2020 10:04PM ET
As a major setback for Teleflex Incorporated (NYSE:TFX) , the FDA has classified the recent voluntary recall of the company’s COMFORT FLO Humidification System as Class I due to health risks associated with its use. The recalled products were from the batch manufactured between October 2014 and June 2019.
On a positive note, products manufactured after June 2019 do not have any issue since those were being packaged with the new COMFORT FLO columns for high flow therapy.
Overall, news of the recall has not yet impacted the share price of Teleflex, which closed at $386.65 on Feb 14, 2020.
More About the Product Recall
The products, which are being recalled by Teleflex, provide a continuous flow of heated and humidified gas to patients using the COMFORT FLO system in professional health care settings. The recalled products contain only one white reservoir clamp on the feed tube unlike the new products, which contain two blue reservoir clamps.
The product recall was initiated by the company after receiving various complaints of water ingress, where medical intervention was required for several patients to prevent serious injury or permanent damage. Water ingress can lead to potential health hazards like aspiration of fluid into the nose and lungs, leading to oxygen desaturation.
Even though no deaths have been reported so far, the company has received reports of serious consequences like fluid aspiration and subsequent desaturation, requiring invasive respiratory support. Another incident was that of aspiration, with desaturation and bradycardia, which required bag mask ventilation.
Recent Product Recall
In October 2019, Teleflex recalled certain products of GaleMed Corporation’s (third-party manufacturer) Babi.Plus 12.5 cm H2O Pressure Relief Manifold (distributed between October 2018 and May 2019) due to a Medical Device Recall Notice received from GaleMed. GaleMed also received two reports of device malfunctions, where the device vented gas below the stated pressure. Though voluntary, the recall was also classified as Class I by the FDA.
The issue with the device was that the bubble continuous positive airway pressure (BCPAP) system would not hold pressure. This was due to the pressure relief manifold’s (PRM) internal mechanism being lodged in the upper valve chamber, preventing engagement with the valve seat.
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Price Performance
Shares of Teleflex have gained 35.8% in the past year compared with the Zacks Investment Research
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