Device product
Phoenix AP AST Indicator Bag, Catalog Number 246006
Z-0935-2019
Product summary
- Event
- Event 81952
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62880 total
- Official record key
device-enforcement:Z-0935-2019
Official wording
Reason: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
Code information: Batch Numbers 8234684 8234533 8225579 8225578 8218607 8218605 8213696 8213635 8213633 8208581 8208579 8206585 8190531 8190530 8170557 8234505 8170562 8159691 8150670 8150669
Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam
Derived failure modes
-
Unknown
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.