Recall Z-2581-2011
GE Healthcare, LLC · initiated April 26, 2011
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.
Codes / lots: 510(k) K911213 Medical Device Listing Number D110124 for year 2009- Lot #2689- Lot #3659 For year 2010 - Lot #0010-Lot #2530
Reason for recall
BP cuffs may not properly inflate due to a leak
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2581-2011
- Initiated
- April 26, 2011
- Posted by FDA
- June 22, 2011
- Terminated
- May 28, 2013
- Product code
- DXQ – Blood Pressure Cuff
- Quantity
- 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
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI