FDA-Device2019-08-21Class II

SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

Suntech Medical, Inc.
Hazard

Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

Sold states
Pakistan
Affected count
80 total cuffs affected; 4 Boxes of 20 cuffs
Manufactured in
507 Airport Blvd Ste 117, N/A, Morrisville, NC, United States
Products
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2277-2019

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