Z-1568-2008

3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper...

Name: Z-1568-2008 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper...
Creator: 3M Company / Medical Division
Published: 2008-03-19
License: https://open.fda.gov/license/

3M Company / initiated 2008-03-19 / Terminated / root cause: manufacturing process

FDA source

3M Company / Medical Division began a recall of 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by... on 2008-03-19. The reason FDA records is "A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate". 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-1568-2008
Status: Terminated
Initiated: 2008-03-19
Posted: 2008-08-08
Terminated: 2012-03-01
Recalling firm: 3M Company
Product: 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized. 3M Health Care 3M Center Bldg 275-4E-011, St. Paul, MN 55144-1000
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers and Distributors were each sent a "Voluntary Product Recall" letter dated 3/17/08 on 3/19/08. The letter states that use of the affected product should immediately be discontinued, stocks should be checked for any remaining inventory, and reprocess any unused packs using the product not from the affected lot or from an alternative supplier. The letter requested consignees to notify 3M whether the facility has affected product or not by sending the "Product Return Form". Replacements will be provided to those with affected products remaining in their stock.
Quantity in commerce: 12,998 cases ( 4 boxes per case & 480 strips per box))
Distribution: Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, CT,DC, DE, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS,MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Product codes and lots: 2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA, 2008-08AA, 2008-10AA, 2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB, 2009-04AA, 2009-05AA, 2009-08AA, 2009-09AA.

Product code JOJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)