Recall Z-0973-2009 ยท NGT Saline, Vascular Access Flush
Excelsior Medical Corp
Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medical, Neptune, NJ. This product is used for the flushing of venous access devices and intravenous tubing.
| Date | Feb 6, 2009 (initiated Jan 13, 2009) |
| Status | Terminated |
| Reason | Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes. |
| Root cause | Packaging process control |
| Action | An Urgent Medical Device Recall letter (dated January 13, 2009) was sent to consignees via certified mail, with return receipt requested. The letter provided the reason for the recall and instructions to discontinue use and return (or destroy) the recalled product. The letter also instructed customers to complete the enclosed Customer Reply Form and fax (866-360-6211) to Excelsior Medical Corporation. If the affected product is destroyed on site, fax a copy of the certificate of destruction with the completed Customer Reply Form. Arrangements will be made by Excelsior Medical Corporation f |
| Quantity | 341,580 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES Excelsior Medical Corp., Dec 9, 2005 |