WAYNE, PA — 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.
The U.S. Food and Drug Administration (FDA) has classified the recall of the COMFORT FLO® Humidification System as a Class I recall. FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Consumers who have affected product should immediately identify all patients that are currently exposed to use of this product, discontinue use, and return all affected product to Teleflex. The recall notice, with a list of affected product codes and lot numbers, can be found through the following link: https://p.widencdn.net/svhco2/EIF-387-Amend-Cust-letter-ack-appx
Consumers with questions may contact the company at 1-866-396-2111; 8 am to 7 pm, ET, Monday through Friday or email [email protected].
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm, or via Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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