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U.S. Department of Health and Human Services

Class 3 Device Recall LeMaitre Vascular AnastoClip GC Vessel Closure SystemLarge Size Models: 4007

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  Class 3 Device Recall LeMaitre Vascular AnastoClip GC Vessel Closure SystemLarge Size Models: 4007 see related information
Date Initiated by Firm September 22, 2010
Date Posted October 28, 2010
Recall Status1 Terminated 3 on September 15, 2011
Recall Number Z-0165-2011
Recall Event ID 56908
510(K)Number K091987  
Product Classification Applier, hemostatic clip - Product Code HBT
Product LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size
Models:
4007-03 Large size 3 Pack
4008-03 Large size 10 Pack
4007-07 Large size 1 Pack
Manufactured by LeMatire Vascular Inc, Burlington, MA 01803
Code Information Lot Number Expiration Date  AGC1015 2012-10 AGC1016 2012-10 AGC1017 2012-10 AGC1018 2012-11 AGC1019 2012-11 AGC1022 2012-11 AGC1023 2012-11 AGC1024 2012-12 AGC1025 2013-01 AGC1027 2013-01 AGC1028 2013-01
Recalling Firm/
Manufacturer		 Lemaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact Same
781-221-2266 Ext. 158
Manufacturer Reason
for Recall		 Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size.
FDA Determined
Cause 2		 Packaging change control
Action LeMaitre Vascular issued an Urgent AnastoClip GC Device Field Safety Notice letter dated Sepember 28, 2010 identifying the affected devices and actions to be taken by customers. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. The letter provides an option for the notified hospital to return the affected product for replacement if unused or if they simply wish to have it corrected. Customers can contact LeMaitre Customer Service for replacement at 800 628-9470.
Quantity in Commerce 108 units
Distribution Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HBT and Original Applicant = LEMAITRE VASCULAR, INC.
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