Reported Jun 19, 2013 · Terminated
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Ste 109 · Tempe, AZ · 85281-2438
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
| — | USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F |
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 lumen support catheter, with a standard luer fitting at the proximal end. The Usher¿ Peripheral is available in a length 130 cm with an angled tip shape. |
- Lot codes and dates
PC USH07ATLot# FCWC10009
- Amount recalled
- 223
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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