Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Hazard
Product contains incorrect chemical indicators in packaging.
What You Should Do
Remedy
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.
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Products
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
- UPC
- UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Units Affected
619 boxes