| Class 2 Device Recall Baxter Auto Syringe AS50 Infusion Pump |  |
Date Initiated by Firm | February 07, 2006 |
Date Posted | March 16, 2006 |
Recall Status1 |
Terminated 3 on March 24, 2008 |
Recall Number | Z-0612-06 |
Recall Event ID |
34580 |
510(K)Number | K945942 |
Product Classification |
Pump, Infusion - Product Code FRN
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Product | Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. |
Code Information |
serial numbers 15060001AB, 15060002AB, 15060004AB/15060013AB, 15060015AB/15060021AB, 15060023AB/15060073AB, 15060075AB, 15060077AB/15060116AB, 15060116AB, 15060118AB/15060126AB, 15060128AB/15060130AB, 15060132AB/15060172AB, 15060174AB/15060209AB, 15070003AB/15070006AB, 15070008AB/15070018AB, 15070021AB, 15070023AB, 15070026AB/15070034AB, 15070037AB15070041AB, 15070044AB/15070047AB, 15070049AB/15070052AB, 15070056AB/15070059AB, 15070066AB, 15070069AB, 15070071AB, 15070072AB, 15070076AB, 15070077AB, 15070079AB, 15070081AB, 15070082AB, 15070084AB, 15070086AB, 15070087AB, 15070092AB, 15070094AB/15070096AB, 15070099AB, 15070101AB, 15070109AB, 15070111AB/15070115AB, 15070117AB, 15070119AB, 15070121AB, 15070122AB, 15070124AB, 15070126AB/15070128AB, 15070130AB/15070132AB, 15070138AB/15070140AB, 15070144AB |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer 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. |
FDA Determined Cause 2 | Other |
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. |
Quantity in Commerce | 282 pumps |
Distribution | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FRN
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