Recall Z-2277-2019— Suntech Medical, Inc.

Name: FDA recall Z-2277-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-03

Class II · Terminated

Class II FDA medical device recall by Suntech Medical, Inc., initiated 2019-06-03, terminated 2020-12-16. It names one FDA 510(k) clearance: K080854. Product: SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20. Reason: 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..

Recalling firm: Suntech Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-03
Terminated: 2020-12-16
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K080854 — DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100Suntech Medical, Inc.·cleared 2008-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.