Phoenix AP AST Indicator Bag, Catalog Number 246006
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-0935-2019
- 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 8234684 8234533 8225579 8225578 8218607 8218605 8213696 8213635 8213633 8208581 8208579 8206585 8190531 8190530 8170557 8234505 8170562 8159691 8150670 8150669
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.