FDA recall Z-1507-2025

Bard Access Systems, Inc. · Class I · device

Product

BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK00066

Reason for recall

Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

Distribution

Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA, IA, NH, ID, DC, WV, KS, NE, SD, ND, WY, AK, OK, OR, AR and the countries of Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, French Polynesia, French Guayana, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic of Korea, Reunion, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Key facts

Status
Ongoing
Initiation date
2025-03-11
Report date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1507-2025