Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
This recall has been terminated (originally issued August 10, 2022).
- Recall Initiated
- August 10, 2022
- Terminated
- October 30, 2024
- Recall Number
- Z-1736-2022
- Quantity
- 619 boxes
- Firm Location
- Mentor, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Product contains incorrect chemical indicators in packaging.
Distribution
Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY
Lot / Code Info
UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Root Cause
Process control
Action Taken
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.