Agency classClass IIOur severity:High FDA (Devices)·Z-1527-2013·Announced 2013-06-19

Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization

Bard Peripheral Vascular is recalling 315 UltraClip breast tissue markers that were distributed without completing the sterilization process.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device distributed without sterilization, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bard Peripheral Vascular (BPV) is recalling 315 units of the UltraClip Dual Trigger Breast Tissue Marker, 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack. The affected devices are sterile, single-use, non-pyrogenic, and prescription-only. The specific lot number is HUWL0010 and the product code is PC 863017D.

The recall was initiated because the UltraClip Dual Trigger Tissue Markers and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process, rendering them non-sterile. The devices were distributed nationwide to customers in 31 states and the District of Columbia.

Healthcare providers and facilities that have received these devices should stop using them immediately and contact Bard Peripheral Vascular for instructions on return or disposal. Patients who have already received these implants should contact their healthcare provider for guidance.

The recalled product

Product: BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Surgical Implants
Hazard: infection
non-sterile
Affected units: 315

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

PC 863017D
Lot: HUWL0010

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Bard Peripheral Vascular Inc

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Same hazard · infection