Recall Z-0926-2017 ยท NGT Saline, Vascular Access Flush
Nurse Assist, Inc
Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
| Date | Jan 3, 2017 (initiated Oct 4, 2016) |
| Status | Terminated |
| Reason | Potential contamination with B. cepacia. |
| Root cause | Unknown/Undetermined by firm |
| Action | Nurse Assist, Inc. sent an Urgent Medical Device Recall letter dated October 4, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use, a Returned Goods Authorization would be provided for return of the affected product. If product was further distributed consignees were instructed to make every effort to retrieve any of the unused product. For questions consignees should call 800-649-6800 or email productremovalinfo@nurseassist.com. For questions regarding th |
| Quantity | 386,175 syringes |
| Distribution | Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150143 | Normal Saline Flush Nurse Assist, Inc., Aug 31, 2015 |