Z-2277-2019Class II

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

Name: Z-2277-2019 SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Creator: Suntech Medical, Inc.
Published: 2019-06-03
License: https://open.fda.gov/license/

Suntech Medical, Inc. / initiated 2019-06-03 / Terminated / root cause: labeling and UDI

FDA source

Suntech Medical, Inc. began a recall of SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 on 2019-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2277-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-03
Posted: 2019-08-14
Terminated: 2020-12-16
Recalling firm: Suntech Medical, Inc.
Product: SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Product code: DXQ Blood Pressure Cuff
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On June 3, 2019, SunTech Medical sent an Urgent Medical Device Customer Notification to their one consignees advising them of the issue and requesting that they completed the enclosed Recall Acknowledgement Form. This letter further request this consignee to conduct a sub-recall by using the provided Customer Template Letter and Recall Acknowledgement Template.
Quantity in commerce: 80 total cuffs affected; 4 Boxes of 20 cuffs
Distribution: Pakistan
Product codes and lots: Catalog # 98-0400-98 Lot Number: A4H201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2277-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2277-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14

Product code DXQ

K080854Class IIDisposable Blood Pressure Cuff, Model Dc100Suntech Medical, Inc. / cleared 2008-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)