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U.S. Department of Health and Human Services

Class 3 Device Recall LeMaitre Vascular AnastoClip GC Vessel Closure SystemMedium Size Models: 400702

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 Class 3 Device Recall LeMaitre Vascular AnastoClip GC Vessel Closure SystemMedium Size Models: 400702see related information
Date Initiated by FirmSeptember 22, 2010
Date PostedOctober 28, 2010
Recall Status1 Terminated 3 on September 15, 2011
Recall NumberZ-0164-2011
Recall Event ID 56908
510(K)NumberK091987 
Product Classification Applier, hemostatic clip - Product Code HBT
ProductLeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium size 3 Pack 4008-02 Medium size 10 Pack 4007-06 Medium 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
FEI Number 1220948
Recalling Firm/
Manufacturer		 Lemaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information ContactSame
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
ActionLeMaitre 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.
DistributionNationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.
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 = HBT
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