Recalls / —

—#34096

Product

Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021

FDA product code

BYD — Condenser, Heat And Moisture (Artificial Nose)

Device class

Class 1

Medical specialty

Anesthesiology

510(k) numbers

K874597

Affected lot / code info

Lot Numbers 103166A, 103353A, 907001 to 912297, 001067 to 111623, K101587 to K522160

Why it was recalled

Sterility of the device is compromised due to lack of package integrity

Root cause (FDA determination)

Other

Action the firm took

Smiths Medical notified Direct Customers were contacted via letter delivered by Federal Express on July 13, 2004. Dealers were contacted via letter starting on July 14, 2004.Users are requested to return product.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2004-07-13

Posted by FDA

2004-07-22

Terminated

2012-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.