FDA-Device2026-02-25Class IIPACKAGING DEFECT
Bard Broviac and Hickman central venous catheters recalled for compromised sterile packaging
What this means
Bard Peripheral Vascular is recalling multiple central venous catheter trays and kits because the outer packaging may be damaged, which could compromise the sterile barrier that protects the medical device. The recall affects several Broviac and Hickman catheter products with specific lot numbers manufactured between April 2028 and August 2030.
- Check if your facility has any affected catheters by matching the lot numbers listed in the recall
- Do not use any catheters from the recalled lots
- Contact Bard Peripheral Vascular or the FDA for instructions on returning or disposing of affected products
- Review your inventory of Broviac and Hickman catheter stock immediately
The agency's original wording
Hazard
Due to damage to outer tray that can potentially compromise the sterile barrier
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
14,935 units
Manufactured in
1625 W 3rd St Bldg 1, 850 W. Rio Salado Prkwy., Tempe, AZ, United States
Products
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2026Want us to check the next one for you?
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