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.
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 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 94085
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Catheters
- Hazard
- 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
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.
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