Recalls / —

—#34927

Product

Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000

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: 0, 1, 911, 912, K1, K2, K50, K51, K52

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 #34927. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.