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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 Infuser see related information
Date Initiated by Firm September 21, 2004
Date Posted November 02, 2004
Recall Status1 Terminated 3 on February 07, 2005
Recall Number Z-0062-05
Recall Event ID 30168
510(K)Number K030739  K992044  
Product Classification Pump, Infusion - Product Code FRN
Product Infusion Dynamics Power Infuser pump. Model number M100B-3A
Code Information Serial numbers 13-05863 through 13-05929 and 13-6005 through 13-06036
Recalling Firm/
Manufacturer		 Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics
5209 Militia Hill Rd
Plymouth Meeting PA 19462-1216
For Additional Information Contact Andrew 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
Action The 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 Commerce 255 units
Distribution The 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 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 = INFUSION DYNAMICS, INC.
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