BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr
Summary
The FDA issued a Class II for BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr by C.R. Bard Inc. Reason: Cather packaging may contain the incorrect French size..
Details
Source
Device Recall
External ID
Z-2074-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Lot/Code Info: REF:21110 -Lot:JUJX0267/UDI:801741075506; REF:21112 -Lot:JUJX0258/UDI:801741075513; REF:21114 - Lots:JUJV0864 & JUJW5009/UDI:801741075520; REF:21120 -Lot:JUJY9171/UDI:801741075551
Reason for Recall
Cather packaging may contain the incorrect French size.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-03
Company
Covington, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 413 device-related FDA actions this month.
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (C.R. Bard Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does C.R. Bard Inc have FDA actions?
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2074-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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