Z-0463-05

Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult...

Name: Z-0463-05 Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult...
Creator: Smiths Medical ASD, Inc.
Published: 2004-04-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-04-01 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult Disposable Anesthesia Breathing Circuit ***1-Breathing... on 2004-04-01. The reason FDA records is "Mislabeled: Product labeled as non-latex actually contains a latex breathing bag". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0463-05
Status: Terminated
Initiated: 2004-04-01
Posted: 2005-02-01
Terminated: 2005-02-08
Recalling firm: Abbott Medical
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***.
Reason for recall: Mislabeled: Product labeled as non-latex actually contains a latex breathing bag.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smiths Sales Representatives and Sales Regional Manager visited the distributor and removed 33 cases.
Quantity in commerce: 357 cases
Distribution: FL
Product codes and lots: Lot Numbers: 205614, 223919, 504882

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)