Class 2 Device Recall 3M Comply

• Date Initiated by Firm: August 09, 2006
• Date Posted: October 11, 2006
• Recall Status: Terminated on May 25, 2007
• Recall Number: Z-0027-2007
• Recall Event ID: 36180
• 510(K)Number: K013228
• Product Classification: Chemical Indicator Strips - Product Code JOJ
• Product: 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
• Code Information: Lot number 2006-12 AA through 2008-06 AB.
• Recalling Firm/ Manufacturer: 3M Company / Medical Division; 3M Center, Bldg 275-05-W-06; South St Paul MN 55411
• Manufacturer Reason for Recall: 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.
• FDA Determined Cause: Other
• Action: The firm initiated a recall of the Comply 1248 product made with the discrepant material. Customer letters were sent on August 14, 2006. Letters notified customers of problem and instructed them to discontinue distribution or use of the product. Then to return all affected product to them.
• Quantity in Commerce: 6248 cases (4 boxes/case)
• Distribution: Nationwide.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JOJ