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BD BBL Sensi Disc Cefepime - 30 ug, used for… recallZ-1018-2024 · Becton Dickinson & Co. · initiated Jan 8, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

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: [email protected]

Recall details

Recall number
Z-1018-2024
Status
Open, Classified
Initiated by the company
Jan 8, 2024
Posted by the FDA
Feb 8, 2024
Recalling firm
Becton Dickinson & Co.
Quantity
2,363,168 total units
Product code
JTN
FDA submissions
K961188
Distribution
Domestic distribution nationwide. International distribution worldwide.

Product description

BD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696

Code information (models, lots, serial numbers)

Catalog No. 231696¿ UDI-DI 30382902316962 Lots 2339439 3118297 3163524 3223410 3243084 3282873 2063393 2119624 2119625 2119626 2147720 2213567 2273732

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93789).

Sources and updates

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