FDAClass IIAugust 21, 2019

SunTech Medical Disposable recall: Labeling Error

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

Why was SunTech Medical Disposable recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog # 98-0400-98 Lot Number: A4H201

Product
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Recalling firm
Suntech Medical, Inc.
Quantity
80 total cuffs affected; 4 Boxes of 20 cuffs
Distribution
Pakistan
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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