Recalls / —
—#34928
Product
Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000
- FDA product code
- BTO — Tube, Tracheostomy (W/Wo Connector)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K922749, K934465
- Affected lot / code info
- Lot numbers starting with: 1, K1, K2, K50
Why it was recalled
Sterility of the device is compromised due to packaging defects
Root cause (FDA determination)
Other
Action the firm took
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 10 Bowman Dr, Keene, New Hampshire 03431-5043
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2004-09-09
- Posted by FDA
- 2004-11-24
- Terminated
- 2012-05-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.