Reported Nov 1, 2017 · Terminated
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18…
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?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm |
| 2 | MC1616, 16 g x 16 cm |
| 3 | MC1816, 18 g x 16 cm |
| 4 | MC1820, 18 g x 20 cm |
| 5 | MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues. |
- Lot codes and dates
- Lot Numbers
REBP0019REBN0342REBN2123REBP1199REBP1419REBP1807REBQ0084REBQ0343REBQ1012REBP1420REBP1809REBP0869REBP1266REBP1267REBP1421REBP1422REBP1810REBQ0087REBQ0088REBQ0347REBQ0811REBQ1014REBP0158REBQ1904REBQ1898REBQ1978REBR0468REBQ2296REBR0474
- Lot Numbers
- Amount recalled
- 110,550 units
Why it was recalled
During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation.
This product could cause temporary or reversible health problems — stop using it.
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