FDA recall Z-2277-2019

Suntech Medical, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

Pakistan

Key facts

Status
Terminated
Initiation date
2019-06-03
Report date
2019-08-21
Termination date
2020-12-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

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