enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC
FDA device recall Z-1972-2012 · posted 2012-07-09 · Terminated
Recall details
- Recalling firm
- Vital Signs Devices, a GE Healthcare Company
- Reason for recall
- The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours.
- Action taken
- GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included customer instructions and a Customer Response Form to be completed and returned to the firm. Contact Customer Service at 1-800-932-0760 for questions regarding this recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LGZ
- Quantity affected
- 11803 cases
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-02-20
- Date posted
- 2012-07-09
- Date terminated
- 2013-08-19
- Location
- Totowa, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 (K060537) | Enginivity, LLC | 2006-06-08 |