—#89837

Product

Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.

FDA product code: BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: Catalog number-- 1570, Lot numbers: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951.

Why it was recalled

The patient end of the 22 cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector and therefore disconnect from the endotracheal tube. A disconnect in ventilator dependent patients without prompt response to the alarm could lead to hypoxia, organ failure, or cardio-respiratory arrest.

Root cause (FDA determination)

Device Design

Action the firm took

Teleflex Medical sent an Urgent Medical Device Recall letter on March 22, 2010 to consignees. They were instructed to: 1) Immediately discontinue use and quarantine any products labeled as AQUA+ FLEX, Catalog number 1570 with the lot numbers provided. 2) Complete and fax the Recall Acknowledgment Form to 866-804-9881. 3) After contact by a Customer Service Representative, who will provide them with a Return Goods Authorization Number, return the product to Teleflex Medical for credit. Letters addressed to distributors instructed them to communicate the recall to any of their customers who have received the product using the customer letter template and acknowledgement form provided by Teleflex Medical. Their customers were to return the product and acknowledgment form to the distributor who would consolidate and return the product to Teleflex Medical. Affected products received by Teleflex Medial will be destroyed upon receipt. For additional instructions or information, contact the firm at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: Worldwide distribution in the states of CA, FL, GA, KY, KS, IL, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI and to the country of Japan.

Timeline

Recall initiated: 2010-03-19
Posted by FDA: 2010-08-13
Terminated: 2011-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.