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Class 3 Device Recall Possis AngioJet XMI Catheter Rapid Exchange |
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Date Initiated by Firm |
May 01, 2007 |
Date Posted |
June 21, 2007 |
Recall Status1 |
Terminated 3 on July 15, 2007 |
Recall Number |
Z-0955-2007 |
Recall Event ID |
37919 |
510(K)Number |
K042874
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Product Classification |
Coronary Catheter - Product Code DXE
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Product |
Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System). |
Code Information |
Model # 104504-001 Lot Nos: 72285 and 72794 |
Recalling Firm/ Manufacturer |
Possis Medical, Inc 9055 Evergreen Blvd Nw Minneapolis MN 55433-5833
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Manufacturer Reason for Recall |
Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form. |
Quantity in Commerce |
45 |
Distribution |
Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI. |
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 = DXE and Original Applicant = POSSIS MEDICAL, INC.
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