|
Class 2 Device Recall Phoenix AST Indicator |
|
Date Initiated by Firm |
December 20, 2018 |
Create Date |
February 23, 2019 |
Recall Status1 |
Terminated 3 on April 10, 2020 |
Recall Number |
Z-0934-2019 |
Recall Event ID |
81952 |
510(K)Number |
K050745
|
Product Classification |
System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
|
Product |
Phoenix AST Indicator, Catalog Number 246004 |
Code Information |
Batch Numbers 8150994 8143513 8114664 8103968 8101893 8094599 8088904 8254800 8247722 8239891 8236927 8236686 8159672 8156625 8150957 8150525 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir Sparks MD 21152-9212
|
Manufacturer Reason for Recall |
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
|
FDA Determined Cause 2 |
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 in Commerce |
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 |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LON and Original Applicant = BECTON, DICKINSON & CO.
|
|
|
|