—#36257

Product

Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult Disposable Anesthesia Breathing Circuit ***1-Breathing Bag Non-Latex***.

Affected lot / code info: Lot Numbers: 205614, 223919, 504882

Why it was recalled

Mislabeled: Product labeled as non-latex actually contains a latex breathing bag.

Root cause (FDA determination)

Other

Action the firm took

Smiths Sales Representatives and Sales Regional Manager visited the distributor and removed 33 cases.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: FL

Timeline

Recall initiated: 2004-04-01
Posted by FDA: 2005-02-01
Terminated: 2005-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36257. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.