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U.S. Department of Health and Human Services

Class 2 Device Recall Infusion Dynamics Power Infuser

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 Class 2 Device Recall Infusion Dynamics Power Infusersee related information
Date Initiated by FirmSeptember 21, 2004
Date PostedNovember 02, 2004
Recall Status1 Terminated 3 on February 07, 2005
Recall NumberZ-0062-05
Recall Event ID 30168
510(K)NumberK030739 K992044 
Product Classification Pump, Infusion - Product Code FRN
ProductInfusion Dynamics Power Infuser pump. Model number M100B-3A
Code Information Serial numbers 13-05863 through 13-05929 and 13-6005 through 13-06036
FEI Number 3002608078
Recalling Firm/
Manufacturer		 Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics
5209 Militia Hill Rd
Plymouth Meeting PA 19462-1216
For Additional Information ContactAndrew Fleischacker
610-941-0136 Ext. 114
Manufacturer Reason
for Recall		Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position.
FDA Determined
Cause 2		Other
ActionThe recalling firm issued a recall letter dated 9/20/04 to their customers informing them of the problem and the need to return the units.
Quantity in Commerce255 units
DistributionThe products were shipped to dealers in TX, MO, and VT; medical facilities in CA, NV, and NY. The product was also shipped to government accounts in PA and Germany.
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
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