Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07
FDA device recall Z-2581-2011 · posted 2011-06-22 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- BP cuffs may not properly inflate due to a leak
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DXQ
- Quantity affected
- 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, N
- Date initiated
- 2011-04-26
- Date posted
- 2011-06-22
- Date terminated
- 2013-05-28
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUFFABLE (K911213) | Biomedical Dynamics, Inc. | 1991-08-07 |