FDA Medical Device Recalls (openFDA)
LMA North America Inc: LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202
- Recall number
- Z-1053-03
- 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
- Status
- Terminated
- Initiated
- 2003-06-18
- Posted
- 2003-07-29
- Terminated
- 2003-11-03
- Reason
- Sterility cannot be assured
- 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
- 2,579
- Distribution
- Nationwide
- Lot, serial or model codes
- Lots FH041202 and FJ021202
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAE
- Firm FEI
- 3001338204
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28