Phoenix AST-s Indicator, Catalog Number 246009
This recall has been terminated (originally issued December 20, 2018).
- Company
- Becton Dickinson & Co.
- Recall Initiated
- December 20, 2018
- Terminated
- April 10, 2020
- Recall Number
- Z-0933-2019
- Quantity
- 62880 total
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
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
Lot / Code Info
Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Product Advisory letters dated 12/20/18 were sent to customers. Amended Urgent Medical Device Product Advisory letters dated 1/23/19 were also sent to customers.