Recall Z-2581-2011 ยท DXQ Blood Pressure Cuff
GE Healthcare, LLC
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.
| Date | Jun 22, 2011 (initiated Apr 26, 2011) |
| Status | Terminated |
| Reason | BP cuffs may not properly inflate due to a leak |
| Root cause | 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 qu |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911213 | CUFFABLE Biomedical Dynamics, Inc., Aug 7, 1991 |