Recall Z-0165-2011

Lemaitre Vascular, Inc. · initiated September 22, 2010

Terminated

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

Codes / lots: 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

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: Packaging change control

Action taken

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.

Details

Recall number
Z-0165-2011
Initiated
September 22, 2010
Posted by FDA
October 28, 2010
Terminated
September 15, 2011
Product code
HBT – Applier, Hemostatic Clip
Quantity
108 units
Distribution
Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.
Recalling firm
Lemaitre Vascular, Inc., Burlington, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0164-2011 LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium…Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and… 09/22/2010Terminated