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U.S. Department of Health and Human Services

Class 2 Device Recall SJM Peel Away Introducer

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 Class 2 Device Recall SJM Peel Away Introducersee related information
Date Initiated by FirmJune 24, 2009
Date PostedAugust 17, 2009
Recall Status1 Terminated 3 on March 29, 2012
Recall NumberZ-1713-2009
Recall Event ID 52457
510(K)NumberK791129 
Product Classification Wire, guide, catheter - Product Code DQX
ProductSJM 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.
FEI Number 2182269
Recalling Firm/
Manufacturer		 St. Jude Medical
14901 DeVeau Place
Minnetonka MN 55345
For Additional Information Contact
952-933-4700
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.
FDA Determined
Cause 2		Labeling mix-ups
ActionThe 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 Commerce200
DistributionOUS only: Belgium.
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 = DQX
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