—#128577

Product

Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.

FDA product code: CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Catalog Number: 1696, Lot numbers: 02K1301986, 02L1300010, 02L1300037, 02L1301081, 02L1301783, 02M1300190, 02M1300236, 02A1400518 02A1401286, 02A1402358, 02B1400178, 02B1400715 & 02B1401320.

Why it was recalled

The temperature probe does not properly connect to the temperature port.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Teleflex Medical sent an Urgent Medical Device Recall Notification dated July 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service 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 - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines

Timeline

Recall initiated: 2014-07-09
Posted by FDA: 2014-07-23
Terminated: 2017-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128577. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.