Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
FDA Recall Z-0612-06 · Posted 2006-03-16
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2006-02-07
Date Terminated2008-03-24
Product Quantity282 pumps
Reason for Recall
A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.
Firm Action
Baxter sent Urgent Device Correction letters dated 2/7/06 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for the affected pumps to be susceptible to electro-static discharge, which could increase the potential to fail during use, causing the pump to stop infusing and issue an audible and visual alarm. The accounts were asked to immediately take the pump out of service, contact Baxter at 1-800-843-7867 to arrange for the return of the pumps in order to replace the non-conforming gasket, and complete and return the enclosed reply form confirming receipt of the letter. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Root Cause
Other
Distribution Pattern
Nationwide. Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kentucky, Louisiana, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, West Virginia
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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