Z-1197-2007

Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in...

Name: Z-1197-2007 Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in...
Creator: Alcon Research, Ltd
Published: 2007-07-11
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2007-07-11 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, Ltd began a recall of Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each on 2007-07-11. The reason FDA records is "Mislabeled: boxes actually contained Tri-Fact needles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1197-2007
Status: Terminated
Initiated: 2007-07-11
Posted: 2007-08-25
Terminated: 2007-08-28
Recalling firm: Alcon Laboratories
Product: Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each.
Product code: HMX Cannula, Ophthalmic
Reason for recall: Mislabeled: boxes actually contained Tri-Fact needles
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2 boxes
Distribution: CA.
Product codes and lots: Catalog number 8065420920, Lot number 700894M.

Product code HMX

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)