The Recall Desk

FDA (Devices) recall action 64276

Bard Peripheral Vascular Inc recalled 4 products on 2013-06-19

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2013-06-19
Critical
0
Units
1,370

Why these products were recalled

Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··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.

    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, Te
    Category
    Distribution
    33 states
  • HighFDA (Devices)··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.

    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, Te
    Category
    Distribution
    33 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    33 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    33 states