Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.
FDA device recall Z-1532-2010 · posted 2010-04-29 · Terminated
Recall details
- Recalling firm
- Steritec Products Mfc. Co., Inc.
- 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 products. There is insufficient data on file to support the shelf life dating on the product labeling.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOJ
- Quantity affected
- 63 cases
- Distribution
- Nationwide distribution: IL, MI, NY, OH, VA
- Date initiated
- 2009-07-15
- Date posted
- 2010-04-29
- Date terminated
- 2010-06-28
- Location
- Englewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSS-CHECKS P (K972300) | Steritec Products Mfg Co, Inc. | 1998-03-25 |