Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is
FDA device recall Z-2761-2015 · posted 2015-09-11 · Terminated
Recall details
- Recalling firm
- Medivators, Inc.
- Reason for recall
- Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
- Action taken
- Medivators sent an "Urgent Medical Device" recall letter, dated August 4, 2015, via email. The letter described the issue, identified the affected lot, requested the product be quarantined, and to contact Medivators for return instructions and credit or no-charge replacement product. A response form was requested to be returned to Medivators. Customers with questions can contact Medivators Product at 763-553-3348.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 840 units
- Distribution
- US Distribution to the states of CA and MI.
- Date initiated
- 2015-08-03
- Date posted
- 2015-09-11
- Date terminated
- 2015-11-04
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCOR HPH 700 HEMOCONCENTRATOR (K983085) | Minntech Corp. | 1998-11-13 |