HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709. Use to add water vapor to a
FDA device recall Z-2790-2011 · posted 2011-07-12 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.
- Action taken
- 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
- Status
- Terminated
- Product code
- BTT
- Quantity affected
- 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, Philippin
- Date initiated
- 2011-06-06
- Date posted
- 2011-07-12
- Date terminated
- 2014-05-01
- Location
- Durham, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 (K993355) | Hudson Respiratory Care, Inc. | 2000-05-24 |