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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Sensi Disc Ciprofloxacin

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  Class 2 Device Recall BD BBL Sensi Disc Ciprofloxacin see related information
Date Initiated by Firm January 08, 2024
Date Posted February 08, 2024
Recall Status1 Open3, Classified
Recall Number Z-1027-2024
Recall Event ID 93789
510(K)Number K874425  
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
Product BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
Code Information Catalog No. 231657¿ UDI-DI 00382902316572 Lots 1060926 1279842 2028533 2091948 2301402 3214964 3248370; Catalog No. 231658¿ UDI-DI 30382902316580 Lots 1335458 2336475 3062295 3093427 3163048 3214964 3248370 0344330 1007112 1060926 1127037 1279842 1335457 2028533 2028547 2091948 2091980 2301402 2336474
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
Manufacturer Reason
for Recall
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
FDA Determined
Cause 2
Process control
Action On January 8, 2024, the firm notified customers through URGENT Medical Device Product Correction letters. Users were instructed to cease use of catalog number 291270, and to refrain from conducting AST for H. influenzae with impacted Sensi-Discs. Customers should destroy any units of catalog number 291270 in their inventory. Customers should share and post the recall notification within their facility network and forward to any customers to whom they may have distributed the product. Future lots of affected Sensi-Disc products (excluding catalog number 291270) will be labeled with a sticker notifying customers "This product should not be used for the semi-quantitative in vitro susceptibility testing of Haemophilus influenzae." Identify impacted lot numbers: https://legacy.bd.com/alerts-notices/IDS-23-4851.asp For customer questions: Phone: 1-844-823-5433 Say "Recall when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Quantity in Commerce 2,363,168 total units
Distribution Domestic distribution nationwide. International distribution worldwide.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JTN and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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