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U.S. Department of Health and Human Services

Class 2 Device Recall Bllod Pressure Cuffs Disposable, Neonate

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  Class 2 Device Recall Bllod Pressure Cuffs Disposable, Neonate see related information
Date Initiated by Firm June 03, 2019
Create Date August 14, 2019
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-2277-2019
Recall Event ID 83070
510(K)Number K080854  
Product Classification blood pressure cuff - Product Code DXQ
Product SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Code Information Catalog # 98-0400-98 Lot Number: A4H201 
Recalling Firm/
Manufacturer		 Suntech Medical, Inc.
507 Airport Blvd Ste 117
Morrisville NC 27560-8200
For Additional Information Contact Customer Service
919-654-2332
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXQ and Original Applicant = SUNTECH MEDICAL, INC.
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