LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03 Large size 10
FDA device recall Z-0165-2011 · posted 2010-10-28 · Terminated
Recall details
- Recalling firm
- Lemaitre Vascular, Inc.
- 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.
- 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.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- HBT
- Quantity affected
- 108 units
- Distribution
- Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.
- Date initiated
- 2010-09-22
- Date posted
- 2010-10-28
- Date terminated
- 2011-09-15
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP (K091987) | LeMaitre Vascular, Inc. | 2010-04-23 |