FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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.
- Recall number
- Z-2790-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-06-06
- Posted
- 2011-07-12
- Terminated
- 2014-05-01
- Reason
- The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K993355"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28