510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2790-2011

HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709. Use to add water...

Teleflex Medical / initiated 2011-06-06 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

Teleflex Medical began a recall of 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... on . The reason FDA records is "The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-2790-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
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.
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall
The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.
Root cause tag
packaging
FDA root cause
Packaging
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.
Quantity in commerce
228, 960 eaches
Distribution
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.
Product codes and lots
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.