Z-1053-03

LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot...

Name: Z-1053-03 LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot...
Creator: LMA North America Inc
Published: 2003-06-18
License: https://open.fda.gov/license/

LMA North America Inc / initiated 2003-06-18 / Terminated / root cause: sterility

FDA source

LMA North America Inc began a recall of LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202 on 2003-06-18. The reason FDA records is "Sterility cannot be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1053-03
Status: Terminated
Initiated: 2003-06-18
Posted: 2003-07-29
Terminated: 2003-11-03
Recalling firm: LMA North America Inc
Product: LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: Sterility cannot be assured
Root cause tag: sterility
FDA root cause: Other
Action: Recall letters were issued on June 18, 2003 to customers. It requests return of product and included a request to fax back inventory description.
Quantity in commerce: 2,579
Distribution: Nationwide
Product codes and lots: Lots FH041202 and FJ021202

Product code CAE

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)