Phoenix AST Indicator, Catalog Number 246004
FDA Recall #Z-0934-2019 — Class II — December 20, 2018
Product Description
Phoenix AST Indicator, Catalog Number 246004
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 8150994 8143513 8114664 8103968 8101893 8094599 8088904 8254800 8247722 8239891 8236927 8236686 8159672 8156625 8150957 8150525
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated