Recall Z-1531-2010 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Steritec Products Mfc. Co., Inc.
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.
| Date | Apr 29, 2010 (initiated Jul 15, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 2656 cases |
| Distribution | Nationwide distribution: IL, MI, NY, OH, VA |
| FDA record | Open on fda.gov |