FDA Medical Device Recalls (openFDA)
Alcon Laboratories, Inc: Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
- Recall number
- Z-1644-2009
- Recalling firm
- Alcon Laboratories, Inc
- Product
- Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
- Status
- Terminated
- Initiated
- 2009-04-29
- Posted
- 2009-05-26
- Terminated
- 2009-10-14
- Reason
- Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
- Root cause
- Process control
- Action
- Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.
- Quantity
- 59 surgical paks.
- Distribution
- Worldwide Distribution -- USA and Canada.
- Lot, serial or model codes
- Lot #899513H (for Cat/Item #10240-03), 892675H (for Cat/Item #11077-03), 892670H (for Cat/Item #11187-02) and 894213H (for Cat/Item #13305-01).
- 510(k) numbers
- ["K880961"]
- PMA numbers
- not on file
- Product code
- NGY
- 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