Cuffable Blood Pressure Cuffs…

Date posted by the FDA

June 22, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

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.

Reason

BP cuffs may not properly inflate due to a leak

Distribution pattern

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

Quantity

2,684,996 units

Codes and lots

510(k) K911213 Medical Device Listing Number D110124 for year 2009- Lot #2689- Lot #3659 For year 2010 - Lot #0010-Lot #2530

Recall started

April 26, 2011

Device type

Blood Pressure Cuff

Root cause (FDA)

Device Design

What the company told customers

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.

Recall number

Z-2581-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2581-2011. The agency record governs; check it and the company before acting.