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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Sensi Disc Imipenem

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  Class 2 Device Recall BD BBL Sensi Disc Imipenem see related information
Date Initiated by Firm January 08, 2024
Date Posted February 08, 2024
Recall Status1 Open3, Classified
Recall Number Z-1031-2024
Recall Event ID 93789
510(K)Number K855106  
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
Product BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
Code Information Catalog No. 231644 UDI-DI 00382902316442 Lots 1335006 2056580 2091918 2210318 2301385 3062101 3094134 3118125 3214950; Catalog No. 231645¿ UDI-DI 30382902316450 Lots 3062101 3094134 3118125 3214950 3261103 1335006 2056580 2081151 2091918 2091925 2147704 2210318 2210343 2277500 2301385
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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