Medical device recalls Moderate risk

Stryker Instruments Div. of Stryker Corporation recalls EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip…

Recall date
April 24, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1671-2015
FDA classification
Class II
Brand / firm
Stryker Instruments Div. of Stryker Corporation
Sold / distributed
US Nationwide Distribution including AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, VA, and WI.

Why it was recalled

Potential for the device cannula to overthrow past the intended length.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.

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