Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restric
FDA device recall Z-0588-2008 · posted 2008-01-23 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.
- Action taken
- Baxter on 11/30/07 sent an Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential leaks during filling or use of the infusor. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any clinical/technical questions were directed to the Baxter Healthcare Product Information Center at 1-800-933-0303.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 86,192 units
- Distribution
- Worldwide: USA, Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Portugal, San Marino, Spain, Sweden, United Kingdom, South Africa, Colombia, Argentina, Hong Kong, Australia
- Date initiated
- 2007-11-29
- Date posted
- 2008-01-23
- Date terminated
- 2010-04-29
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES (K062457) | Baxter Healthcare Corporation | 2006-09-21 |