Recall Z-0588-2008 ยท MEB Pump, Infusion, Elastomeric
Baxter Healthcare Corp.
Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Jan 23, 2008 (initiated Nov 29, 2007) |
| Status | Terminated |
| Reason | Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling. |
| Root cause | Process control |
| Action | 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 1-800-933-030 |
| Quantity | 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 and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES Baxter Healthcare Corporation, Sep 21, 2006 |