FDA Medical Device Recalls (openFDA)
Porex Surgical, Inc.: Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.
- Recall number
- Z-1515-06
- Recalling firm
- Porex Surgical, Inc.
- Product
- Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.
- Status
- Terminated
- Initiated
- 2006-07-11
- Posted
- 2006-09-22
- Terminated
- 2007-02-06
- Reason
- Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material
- Root cause
- Other
- Action
- Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.
- Quantity
- 27 units
- Distribution
- Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC, FL, NC, PA, WI and Germany
- Lot, serial or model codes
- Catalog number 7241-Lot number B002E05N
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYA
- Firm FEI
- 1000131961
- Firm city
- Newnan
- Firm state
- GA
- 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