Recall Z-1127-2010 ยท FPA Set, Administration, Intravascular
Arrow International Inc
Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM)Injection Sites and Rotating Male Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc; with 2""Hi-Flo" Stopcocks, Twin Y Injection Sites and Detachable 8" Extension with Retractable Luer-Lock; with Two SmartSite(TM) Y-injection Sites. SmartSite(TM) is a trademark of Alaris Medical Systems,
| Date | Mar 30, 2010 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | Sterility may be compromised. |
| Root cause | Component design/selection |
| Action | 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 27 |
| Quantity | 70,959,969 of total units |
| Distribution | Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- Medical Parameters, Inc., Apr 28, 1983 |