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.
FDA Recall Z-0027-2007 · Posted 2006-10-11
Advertisement
Recalling Firm3M Company / Medical Division
Recall StatusTerminated
Product CodeJOJ
Date Initiated2006-08-09
Date Terminated2007-05-25
Product Quantity6248 cases (4 boxes/case)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement