FDA Medical Device Recalls (openFDA)
Alcon Laboratories, Inc: Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
- Recall number
- Z-0563-2007
- Recalling firm
- Alcon Laboratories, Inc
- Product
- Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
- Status
- Terminated
- Initiated
- 2006-12-22
- Posted
- 2007-03-01
- Terminated
- 2007-06-06
- Reason
- Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
- Root cause
- Other
- Action
- Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level.
- Quantity
- 30 custom surgical packs.
- Distribution
- Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
- Lot, serial or model codes
- Lot #633317H, 645074H, and 629784H.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNN
- Firm FEI
- 1000117501
- Firm city
- Houston
- 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