FDA Medical Device Recalls (openFDA)
Steritec Products Mfc. Co., Inc.: Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.
- Recall number
- Z-1532-2010
- Recalling firm
- Steritec Products Mfc. Co., Inc.
- Product
- Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.
- Status
- Terminated
- Initiated
- 2009-07-15
- Posted
- 2010-04-29
- Terminated
- 2010-06-28
- Reason
- This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their products. There is insufficient data on file to support the shelf life dating on the product labeling.
- Root cause
- Other
- Action
- Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.
- Quantity
- 63 cases
- Distribution
- Nationwide distribution: IL, MI, NY, OH, VA
- Lot, serial or model codes
- Lot Numbers: 070801, 080401, 080501, 080701, 081101.
- 510(k) numbers
- ["K972300"]
- PMA numbers
- not on file
- Product code
- JOJ
- Firm FEI
- 1000125215
- Firm city
- Englewood
- Firm state
- CO
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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