Z-2277-2019 Class II Terminated

Recalled by Suntech Medical, Inc. — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
August 21, 2019
Initiation Date
June 3, 2019
Termination Date
December 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80 total cuffs affected; 4 Boxes of 20 cuffs

Product Description

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 Pattern

Pakistan

Code Information

Catalog # 98-0400-98 Lot Number: A4H201