Agency classClass IIOur severity:High FDA (Devices)·Z-1528-2013·Announced 2013-06-19

Bard MicroSheath and Usher Catheters Recalled for Lack of Sterilization

Bard Peripheral Vascular is recalling 17 MicroSheath and Usher support catheters 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 medical devices that were not sterilized, creating a risk of infection or harm during use. This fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bard Peripheral Vascular (BPV) is recalling 17 units of MicroSheath and Usher support catheters. These single-lumen catheters are intended to create a pathway for other devices in the peripheral vasculature. The specific product code is PK1018-03A, and the lot number is FCWC10010.

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

The affected products were distributed nationwide, including 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. Users should stop using these devices and contact the manufacturer for instructions.

The recalled product

Product: MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Catheters
Hazard: infection
non-sterile
Affected units: 17

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 MS17123
Lot# FCWC10010

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