BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr...
FDA Recall #Z-2075-2025 — Class II — June 3, 2025
Product Description
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Reason for Recall
Cather packaging may contain the incorrect French size.
Recalling Firm
C.R. Bard Inc — Covington, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
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.
Code Information
REF:21312- Lot:JUJX0285 /UDI:801741075605; REF:21314- Lot:JUJX1147 /UDI:801741075612; REF: 21316- Lots:JUJY0895 & JUJX1148 /UDI:801741075629
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated