Recall Z-1507-2025 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems, Inc.
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, CK00
| Date | Apr 16, 2025 (initiated Mar 11, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 3/11/2025, recall notices were distributed to customers and distributors who were asked to do the following: Actions if catheter damage is suspected: 1. Stop any infusion if catheter damage is suspected. 2. Follow your institution's guidelines for catheters with suspected damage. 3. If catheter fracture is confirmed, catheter should be removed and an alternative route for access should be obtained. 4. Report any catheter replacements due to leakage to firm's Complaint Center. Please Take the Following Actions: 1. Destroy all unused product following your institution's process for destru |
| Quantity | 718,461 |
| 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, A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210264 | BD PowerPiCC Catheter Bard Access Systems, Inc., Jul 30, 2021 |