Date Initiated by Firm | May 14, 2010 |
Date Posted | March 26, 2013 |
Recall Status1 |
Terminated 3 on April 11, 2013 |
Recall Number | Z-0996-2013 |
Recall Event ID |
63621 |
510(K)Number | K040899 |
Product Classification |
Pump, infusion - Product Code FRN
|
Product | Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500.
Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. |
Code Information |
Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377. |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 1265 Grey Fox Rd Saint Paul MN 55112-6929
|
For Additional Information Contact | 651-633-2556 |
Manufacturer Reason for Recall | An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions. |
FDA Determined Cause 2 | Device Design |
Action | On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077. |
Quantity in Commerce | 6 |
Distribution | Distributed in the state of NH. |
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
|