Z-0027-2007

3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50...

Name: Z-0027-2007 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50...
Creator: 3M Company / Medical Division
Published: 2006-08-09
License: https://open.fda.gov/license/

3M Company / initiated 2006-08-09 / Terminated / root cause: manufacturing process

FDA source

3M Company / Medical Division began a recall of 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide... on 2006-08-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0027-2007
Status: Terminated
Initiated: 2006-08-09
Posted: 2006-10-11
Terminated: 2007-05-25
Recalling firm: 3M Company
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.
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot number 2006-12 AA through 2008-06 AB.

Product code JOJ

K013228Class II3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. / cleared 2002-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)