LeMaitre Over-the-Wire Embolectomy Catheter 6F recall: Sterility Concern
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
Why was LeMaitre Over-the-Wire Embolectomy Catheter 6F recalled?
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: OTW3099¿
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 4315 total
- 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.
- Recall date
- December 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)