Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Recall
- Recall Number
- Z-1367-2026
- Event Number
- 98222
- Firm
- Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438
- FEI Number
- 2020394
- Product Code
- LJS
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- December 12, 2025
- Posted
- February 13, 2026
Description
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Due to damage to outer tray that can potentially compromise the sterile barrier
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: [email protected]
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.
14,935 units