FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
- Recall number
- Z-1312-2015
- Recalling firm
- Advanced Sterilization Products
- Product
- Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
- Status
- Terminated
- Initiated
- 2014-12-24
- Posted
- 2015-03-23
- Terminated
- 2015-09-04
- Reason
- Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
- Root cause
- Under Investigation by firm
- Action
- A customer notification letter was sent on 12/24/14 to all customers who purchased the expired Tyvek Rolls with STERRAD Chemical Indicator. The letter informs the customers of the problems identified and the actions to be taken.
- Quantity
- 2 units
- Distribution
- Saudi Arabia and Portugal
- Lot, serial or model codes
- Lot No. 68965-1241
- 510(k) numbers
- ["K141693"]
- PMA numbers
- not on file
- Product code
- FRG
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- 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