Z-0165-2011

LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03...

Name: Z-0165-2011 LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03...
Creator: Lemaitre Vascular, Inc.
Published: 2010-09-22
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2010-09-22 / Terminated / root cause: packaging

FDA source

Lemaitre Vascular, Inc. began a recall of 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... on 2010-09-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0165-2011
Status: Terminated
Initiated: 2010-09-22
Posted: 2010-10-28
Terminated: 2011-09-15
Recalling firm: LeMaitre Vascular Inc.
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
Product code: HBT Applier, Hemostatic Clip
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and 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

Product code HBT

K091987Class IIAnastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, AnastoclipLeMaitre Vascular, Inc. / cleared 2010-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)