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Bard Heyman Follower recallZ-2075-2025 · C.R. Bard Inc · initiated Jun 3, 2025

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 C.R. Bard Inc 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

Cather packaging may contain the incorrect French size.

FDA root cause category: Under Investigation by firm

What the company is doing

On June 3, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Recall Notification to affected consignees via. Fed Ex and E-mail. On June 18, 2025, BD issued a updated recall notification to update incorrect lot numbers. BD asked consignees to take the following actions: 1. Immediately Discontinue Use 2. Please check all inventory locations within your institution for impacted lots of BD C.R. Bard Heyman" Follower Straight Tip Fr Sizes 10, 12, 14, 20; Heyman Follower Coude Tip Fr Sizes 12, 14, 16; BARD Urologist s Trays listed on Attachment 2. 3. Immediately quarantine and discard all impacted devices within your facility s control per your facility s procedures 4.Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall. 5. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached updated customer letter to all customers to advise them of this field action notification on BD s behalf. 6.If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. 7.Complete and return the attached Customer Response Form to the BD contact noted on the form

Recall details

Recall number
Z-2075-2025
Status
Open, Classified
Initiated by the company
Jun 3, 2025
Posted by the FDA
Jul 3, 2025
Recalling firm
C.R. Bard Inc
Product code
KOD
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.

Product description

BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316

Code information (models, lots, serial numbers)

REF:21312- Lot:JUJX0285 /UDI:801741075605; REF:21314- Lot:JUJX1147 /UDI:801741075612; REF: 21316- Lots:JUJY0895 & JUJX1148 /UDI:801741075629

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96961).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page