Bard Peripheral Vascular Recalls Hickman and Broviac Catheter Trays Over Sterility Risks
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Bard Peripheral Vascular Inc. has recalled over 14,000 Hickman and Broviac catheter trays because damaged packaging may compromise the sterile barrier of the devices.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on March 3, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Bard Peripheral Vascular Inc. has initiated a voluntary Class II recall of various Hickman and Broviac Central Venous (CV) Catheter trays and kits. The recall was prompted by reports of damage to the outer tray packaging, a defect that can potentially compromise the sterile barrier of the medical equipment.
Which Products Are Affected
A total of 14,935 units are included in this recall. Affected products include various configurations of the following:
- Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Trays and Kits (Catalog: 60060, 600060, 600520, 0600520CE)
- Broviac 6.6 Fr Single-Lumen CV Catheter Trays and Kits (Catalog: 600100, 600120, 600540, 0600100CE, 0600540CE)
- Hickman 7 Fr Dual-Lumen CV Catheter Trays and Kits (Catalog: 600310, 600570, 0600310CE, 0600570CE)
- Hickman 9.6 Fr Single-Lumen CV Catheter Kits (Catalog: 600560, 0600560CE)
- Hickman 10 Fr Triple-Lumen CV Catheter Kits (Catalog: 606560, 0606560CE)
- Hickman 12 Fr Dual-Lumen CV Catheter Trays and Kits (Catalog: 600350, 600620, 0600620CE)
- Hickman 12.5 Fr Triple-Lumen CV Catheter Kits (Catalog: 600650, 0600650CE)
The recall affects numerous lot numbers distributed nationwide across the United States and internationally to countries including Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, and Vietnam.
What You Should Do
Bard Peripheral Vascular Inc. began notifying customers of the issue via letter on December 12, 2025. Healthcare facilities and distributors should immediately check their inventory for the affected catalog and lot numbers. Affected products should be quarantined and handled according to the specific instructions provided in the firm's notification letter.
Why This Matters
The integrity of the sterile barrier is critical for medical devices inserted into the central venous system. If the barrier is compromised, patients are at an increased risk of serious infection or other medical complications during or after the catheterization procedure.
Source
This recall is documented by the FDA under recall number Z-1367-2026.
Original source: FDA Official Notice ↗
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