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U.S. Department of Health and Human Services

Class 2 Device Recall Infusion catheter and Occluding Guide Wire

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 Class 2 Device Recall Infusion catheter and Occluding Guide Wiresee related information
Date Initiated by FirmMay 14, 2008
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on March 08, 2010
Recall NumberZ-2107-2008
Recall Event ID 48445
510(K)NumberK992231 
Product Classification Continuous flush catheter - Product Code KRA
ProductFountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
Code Information Lot numbers: F496042, and F587928.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact
801-208-4119
Manufacturer Reason
for Recall		Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.
FDA Determined
Cause 2		Packaging process control
ActionMerit's six sales reps for the six hospital consignees were notified by letter on 05/14/2008. They were instructed to contact the hospitals and have them immediately quarantine any affected product for return to Merit. If you have any questions please contact Jackie Preece, Customer Service at 1-201-253-1600.
Quantity in Commerce15 units
DistributionClass II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.
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 = KRA
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