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
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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 |
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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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