Z-1531-2010

Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI...

Name: Z-1531-2010 Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI...
Creator: Steritec Products Mfc. Co., Inc.
Published: 2009-07-15
License: https://open.fda.gov/license/

Steritec Products Mfg. Co., Inc. / initiated 2009-07-15 / Terminated / root cause: labeling and UDI

FDA source

Steritec Products Mfc. Co., Inc. began a recall of Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL... on 2009-07-15. The reason FDA records is "This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data on file to support...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1531-2010
Status: Terminated
Initiated: 2009-07-15
Posted: 2010-04-29
Terminated: 2010-06-28
Recalling firm: Steritec Products Mfg. Co., Inc.
Product: Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. There is insufficient data on file to support the shelf life dating on the product labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.
Quantity in commerce: 2656 cases
Distribution: Nationwide distribution: IL, MI, NY, OH, VA
Product codes and lots: Lot numbers: 061001, 061101, 070201, 070401, 070601, 070701, 080101, 080801, 080901, 081001, 0900201, 090301, 090401, 090402

Product code JOJ

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)