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U.S. Department of Health and Human Services

Class 2 Device Recall Model 8100 Series Medley Medication Safety System Pump Module

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  Class 2 Device Recall Model 8100 Series Medley Medication Safety System Pump Module see related information
Date Initiated by Firm November 10, 2004
Date Posted March 03, 2005
Recall Status1 Terminated 3 on September 02, 2005
Recall Number Z-0568-05
Recall Event ID 30451
510(K)Number K950419  K012383  
Product Classification Pump, Infusion - Product Code FRN
Product Model 8100 Series Medley Medication Safety System Pump Module
Code Information Serial Numbers 2326101 thru 9861567
Recalling Firm/
Manufacturer		 Alaris Medical Systems Inc
10221 Wateridge Cir
San Diego CA 92121-2733
For Additional Information Contact William H. Murphy
858-458-7749
Manufacturer Reason
for Recall		 The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.
FDA Determined
Cause 2		 Other
Action A device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.
Quantity in Commerce 55,200
Distribution United States and Canada
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.
510(K)s with Product Code = FRN and Original Applicant = IMED CORP.
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