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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Sensi Disc Ceftriaxone

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 Class 2 Device Recall BD BBL Sensi Disc Ceftriaxonesee related information
Date Initiated by FirmJanuary 08, 2024
Date PostedFebruary 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1024-2024
Recall Event ID 93789
510(K)NumberK850358 
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
ProductBD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635
Code Information Catalog No. 231634 UDI-DI 00382902316343 Lots 1033870 1244758 2026381 2056573 2277488; Catalog No. 231635¿ UDI-DI 30382902316351 Lots 3062288 3158099 3254299 0344489 1033870 1088039 1116107 1148606 1180379 1211608 1244758 1335697 2026381 2028922 2056573 2180451 2277488 2277490
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
ActionOn 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 Commerce2,363,168 total units
DistributionDomestic distribution nationwide. International distribution worldwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JTN
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