FDA Medical Device Recalls (openFDA)
Steris Corporation: Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275F 3 minute Prevacuum Cycle).
- Recall number
- Z-3046-2011
- Recalling firm
- Steris Corporation
- Product
- Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275F 3 minute Prevacuum Cycle).
- Status
- Terminated
- Initiated
- 2011-03-16
- Posted
- 2011-08-22
- Terminated
- 2013-03-19
- Reason
- During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.
- Root cause
- Labeling False and Misleading
- Action
- STERIS sent a Customer Notification letter dated March 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review and follow the Challenge Packs' revised instructions for use enclosed as Attachment A (270-4) and Attachment B (275F 3). For any questions regarding this recall customers were instructed to contact their STERIS Account Manager or call 440-392-7421.
- Quantity
- 2,500
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
- Lot, serial or model codes
- Model #'s: LCC003, LCC005, LCC014 & LCC310.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JOJ
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06