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U.S. Department of Health and Human Services

Class 2 Device Recall Cuffable Blood Pressure Cuffs

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  Class 2 Device Recall Cuffable Blood Pressure Cuffs see related information
Date Initiated by Firm April 26, 2011
Date Posted June 22, 2011
Recall Status1 Terminated 3 on May 28, 2013
Recall Number Z-2581-2011
Recall Event ID 58854
510(K)Number K911213  
Product Classification Blood Pressure Cuffs - Product Code DXQ
Product Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico.

The cuff is used to determine a subject's blood pressure.
Code Information 510(k) K911213 Medical Device Listing Number D110124 for year 2009- Lot #2689- Lot #3659 For year 2010 - Lot #0010-Lot #2530
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Ms. Gwen Braeger
262-548-2608
Manufacturer Reason
for Recall		 BP cuffs may not properly inflate due to a leak
FDA Determined
Cause 2		 Device Design
Action GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 26, 2011 to all affected customers. The letter identified the product, the problem and the action to be taken. Customers were instructed to discontinue use of the product, isolate all affected products, return only unused products and distribute this letter to any other healthcare institutions that are potentially affected by this issue. The letter asks that each customer complete and return the enclosed confirmation form via fax to 800-535-7923, in order to confirm receipt of the notification letter. For any questions, contact your local Vital Signs Account Manager or the International Customer Service at 1-800-932-0760.
Quantity in Commerce 2,684,996 units
Distribution Worldwide Distribution -- USA (nationwide) including Puerto Rico and countries of: Argentina, Australia, Belgium, Canada, Chile, Ecuador, Finland, Germany, Hong Kong, Israel, Italy, Latvia, Lebanon, Nicaragua, Panama, Peru, Saudi Arabia, Slovenia, UK, Uruguay and Venezuela
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 = BIOMEDICAL DYNAMICS, INC.
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