—#66483

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

FDA product code: MEB — Pump, Infusion, Elastomeric
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K062457
Affected lot / code info: 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

Why it was recalled

Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

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.

Timeline

Recall initiated: 2007-11-29
Posted by FDA: 2008-01-23
Terminated: 2010-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.