Agency classClass IIOur severity:High FDA (Devices)·Z-1526-2013·Announced 2013-06-19

Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization

Bard Peripheral Vascular is recalling 815 UltraClip breast tissue markers because they 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 illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Bard Peripheral Vascular (BPV) is recalling 815 units of the UltraClip Dual Trigger Breast Tissue Marker, 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack. The affected products are identified by PC 864017D and lots HUWK1296 and HUWK1297. These sterile, single-use devices were distributed nationwide to 30 states and the District of Columbia.

The recall was initiated because a combination of Bard UltraClip Dual Trigger Tissue Markers and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process. As a result, the affected devices are non-sterile.

Healthcare providers and facilities that have received these specific lots should stop using the devices and contact Bard Peripheral Vascular for further instructions. Consumers should not use these medical devices if they have them in their possession.

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 Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Surgical Instruments
Hazard: infection
non-sterile
Affected units: 815

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 (3)

PC 864017D
Lots: HUWK1296
HUWK1297

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