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LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter… recallZ-0389-2016 · LeMaitre Vascular, Inc. · initiated Oct 21, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from LeMaitre Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

FDA root cause category: Packaging process control

What the company is doing

Consignees were notified of the recall on October 21, 2015 via letter. Consignees were asked to do the following: Identify all catheters with the affected LOT and model numbers in inventory; quarantine all unused catheters from the affected LOTs and record this action in the attached form; send the form via mail, email or fax to Customer Service who will then issue an RMA-number (Return Merchandise Authorization number) for the return shipment and replacement of the products; pass this notice on to all those who need to be aware within your organization and to any organization to which the potentially affected devices have been transferred. For questions concerning this safety notice, please contact Salva Kozin, Quality Assurance Engineer, at 781-221-2266 ext. 183.

Recall details

Recall number
Z-0389-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 21, 2015
Posted by the FDA
Dec 4, 2015
Recalling firm
LeMaitre Vascular, Inc.
Quantity
4315 total
Product code
DXE
FDA submissions
K992368
Distribution
Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

Product description

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.

Code information (models, lots, serial numbers)

Lot Number: NSE1663

Other devices under the same FDA submission

25 devices cleared under K992368 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 72534).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page