ClearanceBrief
Recall Z-1053-03 ยท CAE Airway, Oropharyngeal, Anesthesiology

LMA North America Inc

LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202

DateJul 29, 2003 (initiated Jun 18, 2003)
StatusTerminated
ReasonSterility cannot be assured
Root causeOther
ActionRecall letters were issued on June 18, 2003 to customers. It requests return of product and included a request to fax back inventory description.
Quantity2,579
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.