Recall Z-1367-2026
Bard Peripheral Vascular Inc · initiated December 12, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Codes / lots: 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…
Reason for recall
Due to damage to outer tray that can potentially compromise the sterile barrier
FDA-determined cause: Process control
Action taken
On 01/12/1026, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Removal" Letter informing customers that BD has identified via internal inspections that the packaging of some Hickman Catheter and Broviac Catheter kits may have damage present on the outer tray, potentially compromising the sterile barrier. Affected products were distributed between 06/12/2025 to 11/28/2025. Customers are instructed to: 1. Discontinue use of product listed in the letter and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, forward this notification to ensure that these entities are contacted and informed of the recall. 3. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any required product credit. 4. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. For questions or assistance, contact: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Details
- Recall number
- Z-1367-2026
- Initiated
- December 12, 2025
- Posted by FDA
- February 13, 2026
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Quantity
- 14,935 units
- 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…
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ