FDA recall record

Bard Peripheral Vascular Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff recall — FDA Z-1367-2026

Due to damage to outer tray that can potentially compromise the sterile barrier

Class IIclassification
Z-1367-2026official record ID
Feb 25, 2026report date

Recall record at a glance

Official recordZ-1367-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmBard Peripheral Vascular Inc
Report dateFeb 25, 2026
Recall initiation dateDec 12, 2025
Quantity14,935 units
LocationTempe, AZ, United States

Official product description

Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

Why the product was recalled

Due to damage to outer tray that can potentially compromise the sterile barrier

Distribution information

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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