510(k) K091583 ยท NGT Saline, Vascular Access Flush
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
| Applicant | Medefil, Inc., Glendale Heights IL, US |
| Decision | Substantially Equivalent, Jan 28, 2010 |
| Received | Jun 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130.
b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/C Open, Classified |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.