COMPANY ANNOUNCEMENT
OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
-
Recall Reason DescriptionDue to potential product failures
- Company Name:
- OriGen Biomedical
- Brand Name:
-
Brand Name(s)OriGen
- Product Description:
-
Product DescriptionCatheters
Company Announcement
On August 2, 2017, OriGen Biomedical initiated a recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters.
Customers who have received product from either of these lots of VV28F Reinforced Dual Lumen ECMO Catheters should return any product that they currently have to OriGen Biomedical.
OriGen VV28F Reinforced Dual Lumen ECMO Catheters described below have been recalled:
| Catalog number | Lot number | Manufacture date | Expiration date |
|---|---|---|---|
| VV28F | N18487 | August 14, 2014 | August 30, 2018 |
| VV28F | N18487-1 | April 15, 2015 | April 30, 2019 |
The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less (USA) or less than 29 days (rest of world).
OriGen Biomedical voluntarily recalled OriGen VV28F Reinforced Dual Lumen ECMO Catheters Lot N18487 and N18487-1 after becoming aware of a reported adverse event. OriGen Biomedical has notified the FDA of this action.OriGen Biomedical is aware of two (2) product failures and has received a complaint associated with each of the two (2) product failures. A recurrence of this event could result in serious patient injury.
OriGen Biomedical is notifying distributors and user facilities by e-mail and is arranging for return of all recalled product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
The recalled product was distributed to user facilities in the following USA states:
| Alabama | Arkansas | Arizona |
|---|---|---|
| California | Connecticut | Florida |
| Georgia | Illinois | Indiana |
| Michigan | Missouri | New York |
| Ohio | Oklahoma | Oregon |
| Rhode Island | South Dakota | Texas |
| Tennessee | Washington | Wisconsin |
The recalled product was sold to distributors in the following countries outside the USA:
|
Lot Number |
Country |
|---|---|
| N18487 | Austria |
| Belgium | |
| Chile | |
| Czech Republic | |
| Italy | |
| Kingdom of Saudi Arabia | |
| Netherlands | |
| Poland | |
| SWEDEN | |
| Thailand | |
| USA | |
| N18487-1 | Chile |
| Colombia | |
| India | |
| Kingdom of Saudi Arabia | |
| South Africa | |
| United Arab Emirates | |
| USA |
Consumers with questions may contact OriGen Biomedical at:
OriGen Biomedical Attn: Jackie Jaskula
7000 Burleson Rd, Bldg. D Austin, TX USA 78744
CST Monday – Friday 8:00-5:00 Phone: +1 512 474 7278
Fax: +1 512 617 1503
e-mail: j.jaskula@origen.com