The Recall Desk
HighFDA (Devices)·Z-1529-2013·Announced 2013-06-19

Bard Usher Support Catheters Recalled for Incomplete Sterilization

Bard Peripheral Vascular is recalling 223 Usher Support Catheters that were distributed without completing the sterilization process.

What this means for you

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 injuries or illnesses, 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 223 units of the Usher Support Catheter (Angled Tip, WL130cm, RI 7F; REF USH07AT; Lot# FCWC10009). The recall was initiated because a combination of Bard UltraClip Dual Trigger Tissue Markers and support catheters, including the Usher model, were inadvertently distributed to customers without completing the sterilization process. As a result, the affected devices are non-sterile.

The affected products were distributed nationwide to customers in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, West Virginia, and Wyoming. The devices are manufactured by FlowCardia, Inc., a subsidiary of C. R. Bard, Inc.

Healthcare providers and facilities should stop using the affected Usher Support Catheters immediately. Patients who have received these devices should contact their healthcare provider for further instructions.

The recalled product

Product
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher¿ Peripheral is a single lu
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Catheter
Hazard
Affected units
223

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 USH07AT
  • Lot# FCWC10009

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 →

Related recalls

Same manufacturer · Bard Peripheral Vascular Inc

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Same hazard · infection

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