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Class 2 Device Recall Micro Introducer Kit, 5F Micro Introducer Kit |
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Date Initiated by Firm |
October 20, 2014 |
Date Posted |
December 12, 2014 |
Recall Status1 |
Terminated 3 on April 23, 2015 |
Recall Number |
Z-0563-2015 |
Recall Event ID |
69666 |
510(K)Number |
K083873
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Product Classification |
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
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Product |
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005
Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. |
Code Information |
Lot No. 1302-014 |
Recalling Firm/ Manufacturer |
Pfm Medical Inc 1815 Aston Ave Ste 106 Carlsbad CA 92008-7340
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For Additional Information Contact |
760-758-8749
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Manufacturer Reason for Recall |
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
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FDA Determined Cause 2 |
Process control |
Action |
PFm Medical sent an Urgent Device Recall Notification letter dated November 3, 2014 to all their customers who purchased the catheters and other medical devices. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the recall acknowledgement/reply form and fax it to (760) 758-1167 or email it to customerservice@pfmmedicalusa.com. Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749. |
Quantity in Commerce |
100 units |
Distribution |
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia. |
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 = LJS and Original Applicant = PFM MEDICAL, INC
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