Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medical, Neptune, NJ. Th
FDA device recall Z-0973-2009 · posted 2009-02-06 · Terminated
Recall details
- Recalling firm
- Excelsior Medical Corp
- Reason for recall
- 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.
- Action taken
- 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 for the return of recalled product. Please direct questions to Excelsior Medical Customer Service at 800-487-4276.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 341,580 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-01-13
- Date posted
- 2009-02-06
- Date terminated
- 2009-08-06
- Location
- Neptune, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES (K053120) | Excelsior Medical Corp. | 2005-12-09 |