FDA Device

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.

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