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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Sensi Disc Cefotaxime

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 Class 2 Device Recall BD BBL Sensi Disc Cefotaximesee related information
Date Initiated by FirmJanuary 08, 2024
Date PostedFebruary 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1020-2024
Recall Event ID 93789
510(K)NumberK810564 
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
ProductBD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607; 5 ug, Catalog No. 291308
Code Information Catalog No. 231606 UDI-DI 00382902316060 Lots 2004580 2025164 2090467 2146516 2180432 2301360 3003886; Catalog No. 231607 UDI-DI 30382902316078 Lots 2301360 3062270 3158078 3261093 2004580 2025164 2090467 2146516 2180432 3003886; Catalog No. 291308¿ UDI-DI N/A Lots 2301468 3003046 3093596 3116037 3248537 3248540
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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