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
FDA Recall Z-0588-2008 · Posted 2008-01-23
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeMEB
Date Initiated2007-11-29
Date Terminated2010-04-29
Product Quantity86,192 units
Reason for Recall
Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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