510(k) K111034 ยท NGT Saline, Vascular Access Flush
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
| Applicant | Am USA, Nashville TN, US |
| Decision | Substantially Equivalent, Jul 14, 2011 |
| Received | Apr 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2012 | Amsino Medical USA 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 600 Terminated |
NGT | None listed |
| Sep 15, 2012 | Amsino Medical USA 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60 Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.