FDA Lists Medline Arterial Catheter Recall at Class I, Its Most Serious Category
The agency's enforcement record for recall R-24-278-FGX1 now carries the Class I designation; the record supplied does not state what the classification was before the change.
By AI ReporterFirst reported Feb 6, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 9:05 p.m. ET
The FDA's medical device recall record for 's Integrated Arterial Catheters carries a hazard classification of , recall number . The FDA defines as its most serious category, used where there is a reasonable probability that using the product will cause serious harm or death. The record as supplied does not state which classification applied previously, so the earlier designation has not been established here.
According to the FDA record, the action covers Integrated Arterial Catheters found in Medline arterial line insertion kits, bundles, trays and insertion trays, and was initiated on December 31, 2024. The agency states that a manufacturing issue caused excess material to be present on the catheter hub, and that the material could detach, potentially entering the body at the insertion place or the bloodstream. The agency's stated hazard is that use of affected product may cause serious adverse health consequences, including blockage of blood vessels (embolism) and death. The FDA record says there have been no reported injuries and no reports of death.
The FDA's instructions to users are not to use the Integrated Arterial Catheters in affected item numbers and lots, to check stock immediately for those item numbers and lot numbers, to quarantine all affected product, to remove the affected component before using the kit, and to complete the response form at https://recalls.medline.com using Recall Reference #: . The affected item numbers listed are ART1185B (10653160379225), ART255 (10653160367598), ART350 (10653160362050), ART355 (10653160361817), ART475 (10653160367659), ART535A (10653160367604), ART545A (10653160375135), ART775C (10653160366102), ART840 (10653160366966), ART890B (10653160360834), ART600 (10653160312727) and ART690 (10653160318019), with lot numbers including 2024102590 for ART1185B; 2024082690 and 2024101590 for ART255; 2024093090 for ART350; 2024081290 and 2024112590 for ART355; 2024100790, 2024073090, 2024081590 and 2024090990 for ART475; 2024100890 and 2024080190 for ART535A; 2024102890 for ART545A; 2024101090 for ART600; 2024092490 for ART690; 2024083090 for ART775C; 2024082390 and 2024093090 for ART840; and 2024100990 for ART890B.
An arterial catheter, also called an arterial line, is a thin, flexible tube inserted through the skin into an artery — most often the radial artery at the wrist, or the femoral or brachial artery — so that arterial pressure can be measured directly and continuously and repeated arterial blood samples can be drawn, according to StatPearls on the NIH's NCBI Bookshelf and Wikipedia; those sources note the lines are generally not used to give medication. It is not a consumer product: it is a sterile, single-use device sold in kits and trays to hospitals and clinics and placed by trained clinicians in intensive care units, emergency departments and operating rooms. The FDA's enforcement database records no other enforcement action by this firm, which says nothing about fault in this action.
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