PlainRecalls
FDA Devices Moderate Class II Terminated

(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

Reported: March 9, 2016 Initiated: February 4, 2016 #Z-1038-2016

Product Description

(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

Reason for Recall

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.

Details

Units Affected
5,800 units total
Distribution
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.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 5,800 units total.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 9, 2016. Severity: Moderate. Recall number: Z-1038-2016.