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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix AP AST Indicator Bag

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  Class 2 Device Recall Phoenix AP AST Indicator Bag see related information
Date Initiated by Firm December 20, 2018
Create Date February 23, 2019
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-0935-2019
Recall Event ID 81952
510(K)Number K050745  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product Phoenix AP AST Indicator Bag, Catalog Number 246006
Code Information Batch Numbers 8234684 8234533 8225579 8225578 8218607 8218605 8213696 8213635 8213633 8208581 8208579 8206585 8190531 8190530 8170557 8234505 8170562 8159691 8150670 8150669 
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.
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