FDA Medical devices recall ·
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue… recall
- Recall number
- Z-1367-2026
- Date
- (initiated December 12, 2025)
- Company / brand
- Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1, Tempe, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14,935 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Why was it recalled?
Due to damage to outer tray that can potentially compromise the sterile barrier
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600060 UDI code: (01)00801741051692(17)300728(10)HUKV0547 Lot Number: HUKV0547 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600100 UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600120 UDI code: (01)00801741051715(17)300628(10)HUKU0274 Lot Number: HUKU0274 Product Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600310 UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Product Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600350 UDI code: (01)00801741051777(17)300428(10)HUKR1359 (01)00801741051777(17)300428(10)HUKS0811 (01)00801741051777(17)300628(10)HUKU0316 Lot Number: HUKR1359 HUKS0811 HUKU0316 Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600520 UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)008017
Distribution
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.
States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1367-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.