Phoenix AST-s Indicator, Catalog Number 246009
FDA Recall #Z-0933-2019 — Class II — December 20, 2018
Product Description
Phoenix AST-s Indicator, Catalog Number 246009
Reason for Recall
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
Recalling Firm
Becton Dickinson & Co. — Sparks, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
62880 total
Distribution
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
Code Information
Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated