Recall Record: Class II Recall: 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen… by Bard Access Systems, Inc.

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Bard Access Systems, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Bard Access Systems, Inc. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Bard Access Systems, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Bard Access Systems, Inc.’s FDA history

Argus HQ has recorded 14 total FDA actions tied to Bard Access Systems, Inc.: 0 warning letters, 14 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Is 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UD recalled?

Yes. FDA lists a Class II recall by Bard Access Systems, Inc. for 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling., reported 20260708, with status "Ongoing." FDA recall number: Z-2665-2026.

What is the recall class for Bard Access Systems, Inc.'s recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Related enforcement actions

• Recall: Bard Access Systems, Inc. — Class II recall: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOF… →
• Recall: Bard Access Systems, Inc. — Class II recall: OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG12… →
• Recall: Bard Access Systems, Inc. — Class II recall: 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D… →
• Recall: Bard Access Systems, Inc. — Class II recall: CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478… →
• Recall: Bard Access Systems, Inc. — Class II recall: CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129… →
• Recall: Bard Access Systems, Inc. — Class II recall: CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770… →
• Recall: Bard Access Systems, Inc. — Class II recall: 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Tr… →
• Recall: Bard Access Systems, Inc. — Class II recall: 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 129… →