Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child,

FDA device recall Z-1634-2010 · posted 2010-08-13 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

BTT

Quantity affected

3841 units

Distribution

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.

Date initiated

2010-03-19

Date posted

2010-08-13

Date terminated

2011-11-28

Location

Durham, NC