| Class 2 Device Recall BD BBL Sensi Disc Ofloxacin | |
Date Initiated by Firm | January 08, 2024 |
Date Posted | February 08, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1036-2024 |
Recall Event ID |
93789 |
510(K)Number | K910506 |
Product Classification |
Susceptibility test discs, antimicrobial - Product Code JTN
|
Product | BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672 |
Code Information |
Catalog No. 231672¿
UDI-DI 30382902316726
Lots 1305177
2039254
2180484
2304476
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JTN
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