Recall Z-1197-2007

Alcon Research, Ltd · initiated July 11, 2007

Terminated

Product

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

Codes / lots: Catalog number 8065420920, Lot number 700894M.

Reason for recall

Mislabeled: boxes actually contained Tri-Fact needles

FDA-determined cause: Process control

Action taken

The 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.

Details

Recall number
Z-1197-2007
Initiated
July 11, 2007
Posted by FDA
August 25, 2007
Terminated
August 28, 2007
Product code
HMX – Cannula, Ophthalmic
Quantity
2 boxes
Distribution
CA.
Recalling firm
Alcon Research, Ltd, Fort Worth, TX

Official FDA recall record