FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: Phoenix AST-s Indicator, Catalog Number 246009
- Recall number
- Z-0933-2019
- Recalling firm
- Becton Dickinson & Co.
- Product
- Phoenix AST-s Indicator, Catalog Number 246009
- Status
- Terminated
- Initiated
- 2018-12-20
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
- Root cause
- Under Investigation by firm
- Action
- 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.
- 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
- Lot, serial or model codes
- Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813
- 510(k) numbers
- ["K050745"]
- PMA numbers
- not on file
- Product code
- LON
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28