Recall Z-1367-2026— Bard Peripheral Vascular Inc

Name: FDA recall Z-1367-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-12

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2025-12-12. It names 2 FDA 510(k) clearances: K830256, K830233. Product: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060. Reason: Due to damage to outer tray that can potentially compromise the sterile barrier.

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-12
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

2 on FDA's record

K830256 — NON-STERILE BROVIAC PARENTERAL ALIMI-Evermed, Inc.·cleared 1983-03-01
K830233 — NON-STERILE,SINGLE/SOUBLE LUMEN-CATHEvermed, Inc.·cleared 1983-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.