Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th
FDA device recall Z-0762-2012 · posted 2012-01-14 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
- Action taken
- Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 12,353 units (12 standalone devices/ 12,341 sold in packs)
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-12-02
- Date posted
- 2012-01-14
- Date terminated
- 2012-06-13
- Location
- Arvada, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K020997) | Dideco S.P.A. | 2002-04-04 |