Z-0561-2007

Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual...

Name: Z-0561-2007 Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual...
Creator: Alcon Laboratories, Inc
Published: 2006-12-22
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2006-12-22 / Terminated / root cause: labeling and UDI

FDA source

Alcon Laboratories, Inc began a recall of Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical... on 2006-12-22. The reason FDA records is "Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0561-2007
Status: Terminated
Initiated: 2006-12-22
Posted: 2007-03-01
Terminated: 2007-06-06
Recalling firm: Alcon Laboratories
Product: Alcon Custom-Pak, part #2638-17, 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.
Product code: HNN Knife, Ophthalmic
Reason for recall: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
Root cause tag: labeling and UDI
FDA 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 in commerce: 27 custom surgical packs.
Distribution: Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
Product codes and lots: Lot #627618H and 636380H.

Product code HNN

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)