ClearanceBrief
Recall Z-1197-2007 ยท HMX Cannula, Ophthalmic

Alcon Research, Ltd

Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each.

DateAug 25, 2007 (initiated Jul 11, 2007)
StatusTerminated
ReasonMislabeled: boxes actually contained Tri-Fact needles
Root causeProcess control
ActionThe recalling firm telephoned the hospital on 7/11/07 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm issued a recall letter via FedEx on 7/11/07. The firm's representative is making arrangements to pick up the recalled product.
Quantity2 boxes
DistributionCA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.