FDA recall Z-1048-2025

Product

CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.

Reason for recall

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Distribution

US: FL, KS, ND, PA, WA, WV, IL, WA

Key facts

Status

Ongoing

Initiation date

2024-12-23

Report date

2025-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2025