Recall Z-0165-2011 ยท HBT Applier, Hemostatic Clip
Lemaitre Vascular, Inc.
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
| Date | Oct 28, 2010 (initiated Sep 22, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 108 units |
| Distribution | Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091987 | ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP LeMaitre Vascular, Inc., Apr 23, 2010 |