|
Class 3 Device Recall Verify |
|
Date Initiated by Firm |
August 10, 2022 |
Create Date |
September 10, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1736-2022 |
Recall Event ID |
90763 |
510(K)Number |
K162758
|
Product Classification |
Indicator, physical/chemical sterilization process - Product Code JOJ
|
Product |
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design. |
Code Information |
UDI-DI (GTIN): 10724995088955
Item Number: LCC003, Lot 3411228A |
Recalling Firm/ Manufacturer |
Steris Corporation Hopkins Facility 6515 Hopkins Rd Mentor OH 44060-4307
|
For Additional Information Contact |
Tammy Gentry 440-392-8625
|
Manufacturer Reason for Recall |
Product contains incorrect chemical indicators in packaging.
|
FDA Determined Cause 2 |
Process control |
Action |
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. |
Quantity in Commerce |
619 boxes |
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 |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = JOJ and Original Applicant = STERIS Corporation
|
|
|
|