Recalls / —
—#100421
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.
- FDA product code
- DXQ — Blood Pressure Cuff
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K911213
- Affected lot / code info
- 510(k) K911213 Medical Device Listing Number D110124 for year 2009- Lot #2689- Lot #3659 For year 2010 - Lot #0010-Lot #2530
Why it was recalled
BP cuffs may not properly inflate due to a leak
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- GE Healthcare, LLC
- Address
- 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615
Distribution
- 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
Timeline
- Recall initiated
- 2011-04-26
- Posted by FDA
- 2011-06-22
- Terminated
- 2013-05-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #100421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.