Skip to content
Recall Observatory FDA recall evidence

Device product

Phoenix AP AST Indicator Bag, Catalog Number 246006

Z-0935-2019

December 20, 2018

Class II

Product summary

Firm
Becton Dickinson & Co.
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

    reason.no_named_rule · v1.0.0

    Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.