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Class 2 Device Recall SJM Peel Away Introducer |
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Date Initiated by Firm |
June 24, 2009 |
Date Posted |
August 17, 2009 |
Recall Status1 |
Terminated 3 on March 29, 2012 |
Recall Number |
Z-1713-2009 |
Recall Event ID |
52457 |
510(K)Number |
K791129
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Product Classification |
Wire, guide, catheter - Product Code DQX
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Product |
SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only.
Intended for use for the introduction of catheters into a vessel. |
Code Information |
Lot Number: 2694227. |
Recalling Firm/ Manufacturer |
St. Jude Medical 14901 DeVeau Place Minnetonka MN 55345
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For Additional Information Contact |
952-933-4700
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Manufacturer Reason for Recall |
St. Jude Medical has initiated a voluntary recall of two lots of Peel l Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some 9F products have been labelled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product. St Jude Medical has not received any reports of injures resulting from this mislabelling to date.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
The Consignee was provided with a St. Jude Medical "Urgent Product Information" letter and a doctor Acknowledgement form, via e-mail on June 2009. The letter described the problem and the product involved and advised to isolate and discontinue use of the product involved.
The Consignee will notify the end user and remove any remaining affected units and will notify St Jude Medical of the results. |
Quantity in Commerce |
200 |
Distribution |
OUS only: Belgium. |
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 = DQX and Original Applicant = DAIG CORP.
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