FDA-Device2016-03-09Class II
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Stryker Instruments Div. of Stryker Corporation
Hazard
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Sold states
Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.
Affected count
5,800 units total
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1037-2016Don't want to check this manually?
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