Steris Corporation Hopkins Facility Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Brand
Steris Corporation Hopkins Facility
Lot Codes / Batch Numbers
UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Products Sold
UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Steris Corporation Hopkins Facility is recalling Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have due to Product contains incorrect chemical indicators in packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product contains incorrect chemical indicators in packaging.
Recommended Action
Per FDA guidance
The recalling firm issued customer and distributor letters beginning 08/10/2022 to impacted consignees. Consignees are instructed to: 1) Immediately destroy on-hand inventory of LCC003 Challenge Packs, Lot 3411228A 2) Complete the Medical Device Recall Response Form included with the notification letter and return the complete form via email to: Regulatory_Compliance@steris.com or via fax to 440-392-8963 3) STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KY, LA, MA, MN, MS, MO, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WY
Page updated: Jan 10, 2026