| Class 2 Device Recall Langston Dual Lumen Catheters | |
Date Initiated by Firm | June 09, 2011 |
Date Posted | July 11, 2011 |
Recall Status1 |
Terminated 3 on April 05, 2012 |
Recall Number | Z-2770-2011 |
Recall Event ID |
59003 |
510(K)Number | K061565 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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Product | Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients. |
Code Information |
548264 |
Recalling Firm/ Manufacturer |
Vascular Solutions, Inc. 6464 Sycamore Ct N Maple Grove MN 55369-6032
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For Additional Information Contact | 763-656-4300 |
Manufacturer Reason for Recall | Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264.
Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal,
posing a risk of product contamination. It is possible that a compromised sterile barrier |
FDA Determined Cause 2 | Packaging process control |
Action | Vascular Solutions, Inc. sent an "URGENT MEDICAL DEVICE FIELD ACTION- LOT SPECIFIC" letter dated June 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructed customers to check their inventory for the affected product and provided information on how to examine the product. Customers are to complete and return a Field Action Customer Inventory Form via fax at 763-656-4250 or e-mail at www.vascularsolutions.com. VSI Customer Service will contact customers to set up return shipment of affected product. All affected product will be replaced upon receipt of the shipped product.
Customers should contact their local Sales Representative for questions concerning this recall. |
Quantity in Commerce | 23 (5 pack) boxes |
Distribution | Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, MA, MI, MO, NM, NC, OK, and WA and the countries of Austria and Canada. |
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 = DQO
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