Recalls / —
—#89601
Product
4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer Lock SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K830755
- Affected lot / code info
- Product number MPI-17948.
Why it was recalled
Sterility may be compromised.
Root cause (FDA determination)
Component design/selection
Action the firm took
The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Road, Reading, Pennsylvania 19605
Distribution
- Distribution pattern
- Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.
Timeline
- Recall initiated
- 2010-02-01
- Posted by FDA
- 2010-03-30
- Terminated
- 2012-11-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #89601. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.