CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhaus
FDA device recall Z-0471-2009 · posted 2008-12-29 · Terminated
Recall details
- Recalling firm
- CAS Medical Systems, Inc.
- Reason for recall
- Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Action taken
- CAS Medical Systems notified accounts by letter dated 9/19/08 requesting return and sub-recall be conducted to their accounts. The letter was entitled "UNIFUSOR(R) INFUSION CUFFS AND PRIVATE LABEL (CASMED-MANUFACTURED) INFUSION CUFFS *** URGENT PRODUCT CORRECTION NOTICE." For further information, please contact the firm at 203-488-6056.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KZD
- Quantity affected
- 5,060 pc
- Distribution
- Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.
- Date initiated
- 2008-09-20
- Date posted
- 2008-12-29
- Date terminated
- 2010-08-05
- Location
- Branford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF (K893519) | Statlabs, Inc. | 1989-08-15 |