Z-2075-2025Class II

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

Name: Z-2075-2025 BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Creator: C.R. Bard Inc
Published: 2025-06-03
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2025-06-03 / Open, Classified / root cause: packaging

FDA source

C.R. Bard Inc began a recall of BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316 on 2025-06-03. FDA classified it as Class II and gives the reason as "Cather packaging may contain the incorrect French size". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2075-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-03
Posted: 2025-07-03
Recalling firm: C.R. Bard Inc
Product: BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Product code: KOD Catheter, Urological
Reason for recall: Cather packaging may contain the incorrect French size.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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
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 codes and lots: REF:21312- Lot:JUJX0285 /UDI:801741075605; REF:21314- Lot:JUJX1147 /UDI:801741075612; REF: 21316- Lots:JUJY0895 & JUJX1148 /UDI:801741075629

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2075-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2074-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03
Z-2075-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03
Z-2076-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03

Product code KOD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)