FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263
- Recall number
- Z-0621-2025
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263
- Status
- Open, Classified
- Initiated
- 2024-11-06
- Posted
- 2024-12-05
- Terminated
- not on file
- Reason
- BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
- Root cause
- Under Investigation by firm
- Action
- BD issued URGENT: Medical Device Product Correction (IDS-24-5142) letter on 11/6/24 to Distributors (included Customer Letter) via e-mail, Letter states reason for recall, health risk and action to take: Actions for Clinical Users: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction. 2. Ensure the contents of this notification are read and understood by those within your organization. 3. There are no additional recommendations for repeat testing or review of prior results. 4. Share and post this customer letter with users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 5.Complete the attached Customer Response Form and return to your distributor, whether or not you have any of the impacted material. If you require further assistance, please contact: BD Contact Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com Product Complaints, Technical Questions Post-Market Quality BDRC42@bd.com Recall Questions
- Quantity
- 13,190 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NE, PA and the countries of Canada, Belgium, Singapore, Malaysia.
- Lot, serial or model codes
- UDi-DI: (01)30382902312636 Lot No. (Exp. Date): 2339360 (12/31/2024), 3010977 (01/31/25), 3058508 (03/31/2025), 3184064 (07/02/2025), 3234190 (08/21/2025).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTN
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28