Recall Z-0378-2016
LeMaitre Vascular, Inc. · initiated October 21, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
Codes / lots: Lot Codes: OTW3094¿and OTW3098¿
Reason for recall
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0378-2016
- Initiated
- October 21, 2015
- Posted by FDA
- December 4, 2015
- Terminated
- July 12, 2019
- Product code
- DXE – Catheter, Embolectomy
- 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.
- Recalling firm
- LeMaitre Vascular, Inc., Burlington, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0379-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0380-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0381-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0382-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0383-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0384-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0385-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0386-2016 Class II | LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0387-2016 Class II | LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0388-2016 Class II | LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0389-2016 Class II | LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |
| Z-0390-2016 Class II | LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | 10/21/2015Terminated |