Teleflex Incorporated Announces Worldwide Voluntary Recall of COMFORT FLO Humidification System

Nachrichtenquelle: globenewswire
14.02.2020, 23:00  |  119   |   |   

WAYNE, Pa., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global provider of medical technologies for critical care and surgery, has announced a worldwide voluntary recall of the COMFORT FLO Humidification System.  The recalled products provide a continuous flow of heated and humidified gas to COMFORT FLO patients in professional health care environments. The products involved in the recall are as follows:

Product Name Product Code Lot Numbers
COMFORT FLO Humidification System 2410 See Appendix 1
COMFORT FLO Humidification System with Remote Port Extension 2414
Corrugated COMFORT FLO 2415
Corrugated COMFORT FLO Remote Temp Port 2416

These recalled products were manufactured from October 2014 through June 2019. Products manufactured after June 2019 are now being packaged with our new COMFORT FLO columns for high flow therapy. The recalled product can be identified by the presence of only one white reservoir clamp on the feed tube (distinguishing itself from new product which contains two blue reservoir clamps on the feed tube).  Specific lot codes may be found through the following link: https://p.widencdn.net/svhco2/EIF-387-Amend-Cust-letter-ack-appx

Teleflex is recalling the above product codes and lots due to the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

The potential health consequence of exposure to water ingress is the aspiration of fluid into the nose and lungs that may result in oxygen desaturation. The company has received 102 complaints of water ingress in which intervention has been required on several patients to prevent serious injury or permanent impairment.  The Company has not received any reports of death. In one instance, fluid aspiration and subsequent desaturation required invasive respiratory support including intubation and positive pressure ventilation. In another instance, an infant in a NICU experienced aspiration with desaturation and bradycardia requiring bag mask ventilation. Aspiration in patients requiring supplementary oxygen to prevent hypoxemia also has the potential to result in respiratory arrest, cardiac arrest, permanent brain and/or cardiac injury, and death. The long-range health consequences depend on the degree and duration of desaturation and the rapidity and success of medical interventions to resuscitate the patient.

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