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Terminated

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 Recall Z-2790-2011 · Posted 2011-07-12

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTT
Date Initiated2011-06-06
Date Terminated2014-05-01
Product Quantity228, 960 eaches

Reason for Recall

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

Firm Action

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.

Root Cause

Packaging

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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