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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 Modulesee related information
Date Initiated by FirmNovember 10, 2004
Date PostedMarch 03, 2005
Recall Status1 Terminated 3 on September 02, 2005
Recall NumberZ-0568-05
Recall Event ID 30451
510(K)NumberK012383 K950419 
Product Classification Pump, Infusion - Product Code FRN
ProductModel 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 ContactWilliam 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
ActionA 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 Commerce55,200
DistributionUnited States and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
510(K)s with Product Code = FRN
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