510(k) K960581 ยท KPE Container, I.V.
SECURE EVA DUAL CHAMBER MIXING BAG
| Applicant | Secure Medical Products, Inc., Whitwater WI, US |
| Decision | Substantially Equivalent, Apr 30, 1996 |
| Received | Feb 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2018 | The Metrix Company SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral Open, Classified |
KPE | None listed |
| Sep 21, 2018 | The Metrix Company SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral Open, Classified |
KPE | None listed |
| Sep 21, 2018 | The Metrix Company SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral Open, Classified |
KPE | None listed |
| Sep 21, 2018 | The Metrix Company SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with paren Open, Classified |
KPE | None listed |
| Sep 21, 2018 | The Metrix Company SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with paren Open, Classified |
KPE | None listed |
| Sep 21, 2018 | The Metrix Company SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with paren Open, Classified |
KPE | None listed |
| Sep 21, 2018 | The Metrix Company ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be fi Open, Classified |
KPE | None listed |
| Sep 21, 2018 | The Metrix Company ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be fi Open, Classified |
KPE | None listed |
| Jun 23, 2016 | The Metrix Company Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL Terminated |
NEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.