FDA Medical Device Recalls (openFDA)
Codman & Shurtleff, Inc.: Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
- Recall number
- Z-0094-2011
- Recalling firm
- Codman & Shurtleff, Inc.
- Product
- Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
- Status
- Terminated
- Initiated
- 2010-07-16
- Posted
- 2010-10-20
- Terminated
- 2012-07-09
- Reason
- Surgical Pattie x-ray stripe (radio-opaque marker) became detached
- Root cause
- Process control
- Action
- Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.
- Quantity
- 4407 boxes (20 pouches of 10 patties)
- Distribution
- Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
- Lot, serial or model codes
- Lot numbers: EB514 FB465 GB498 GB449 HB544 HB545 KB438 KB538 KB436 KB527 LB554 LlB555 AC464 421417 421418 421419 422512 423826 423076 423827 423828 423829 423830 423075 HB499
- 510(k) numbers
- ["K880402"]
- PMA numbers
- not on file
- Product code
- HBA
- Firm FEI
- 3002947440
- Firm city
- Raynham
- Firm state
- MA
- 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