| | Class 2 Recall
Baxter Single Day INFUSOR System |  |
| Date Posted |
January 23, 2008 |
| Recall Number |
Z-0588-2008 |
| Product |
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 |
| Code Information |
Lot Numbers: 07E037, 07E038, 07E039, 07E055, 07E056, 07E057, 07F015, 07F029, 07F030, 07F039, 07G003, 07G004, 07G043, 07H004, 07H005, 07H006, 07H035, 07H036, 07H037, 07H057, 07H059, 07H061, 07H074, 07J016, 07J018, 07J052, 07J054, and 07K020
|
Recalling Firm/
Manufacturer |
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073 |
| For Additional Information Contact |
Center for One Baxter
800-422-9837
|
Reason for
Recall |
Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.
|
| 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 1-800-933-0303. |
| Quantity in Commerce |
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. |
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