—#100876

Product

HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709. Use to add water vapor to a dry medical gas for administration to a patient.

FDA product code: BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K993355
Affected lot / code info: Catalog Number: 003-40, Lot numbers: 738107, 741107, 762107, 764107 and 766107; Catalog number: 003-40F, Lot number: 733107; Catalog number: 003-40J, Lot number: 740107; Catalog number: 000-40, Lot numbers: YK24 and YL11; Catalog number: 006-40, Lot number: 137106; Catalog number: 006-40F, Lot numbers: 122106 and 123106; Catalog number: 006-40J, Lot numbers: 135106 and 136106; Catalog number: 400340, Lot numbers: 730107, 731107, 732107, 734107 and 735107.

Why it was recalled

The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.

Root cause (FDA determination)

Packaging

Action the firm took

Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 6, 2011 to all affected customers. The letter described the product, problem, and the action to be taken. The letter instructs customers to discontinue use and quarantine the affected product. Customers must complete and return a Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service. A representative will contact customers with instructions on how to return the affected product. Customers with no affected product are also instructed to complete and return the form to verify receipt of the notification. Contact Customer Service at 1-866-246-6990 if you have questions regarding this recall. and a record of returns. A third letter was addressed to the Risk Manager with the above instructions.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, MI, MN, MO, MS, NM, NE, NY, OH, OK, PA, TX, VA, WI and WM and the countries of Japan, Philippines, and Thailand.

Timeline

Recall initiated: 2011-06-06
Posted by FDA: 2011-07-12
Terminated: 2014-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.