—#142044

Product

Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column

FDA product code: BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K031383
Affected lot / code info: Lot Numbers : 02K1300128 and 02L1302324

Why it was recalled

Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.

Root cause (FDA determination)

Process control

Action the firm took

Teleflex sent an "Urgent Medical Device Recall Notification" dated April 17, 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 voluntary 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: US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA.

Timeline

Recall initiated: 2014-04-17
Posted by FDA: 2015-12-15
Terminated: 2015-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142044. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.