FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1197-2007
- Recalling firm
- Alcon Research, Ltd
- Product
- Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each.
- Status
- Terminated
- Initiated
- 2007-07-11
- Posted
- 2007-08-25
- Terminated
- 2007-08-28
- Reason
- Mislabeled: boxes actually contained Tri-Fact needles
- 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
- 2 boxes
- Distribution
- CA.
- Lot, serial or model codes
- Catalog number 8065420920, Lot number 700894M.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- 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