Reported Aug 14, 2019 · Terminated
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF…
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 Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV
- Product UsageIndicated for use in acquiring tissue for diagnosing breast abnormalities
- Lot codes and dates
Lot numbers VTCT0273VTCT0308VTCT0309VTCU0351VTCU0352VTCW0451VTCW0452VTCW0453VTCX0485VTCX0486VTCX0487VTCY0548VTCY0549VTCY0550VTCZ0642VTCZ0643VTCZ0644and VTCZ0645
- Amount recalled
- 29,918 units
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
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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