Phoenix AST Indicator, Catalog Number 246004
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-0934-2019
- 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 8150994 8143513 8114664 8103968 8101893 8094599 8088904 8254800 8247722 8239891 8236927 8236686 8159672 8156625 8150957 8150525
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.