510(k) K090905 ยท LHI Set, I.V. Fluid Transfer
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Apr 27, 2009 |
| Received | Apr 1, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2013 | B. Braun Medical, Inc. 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000
Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Terminated |
LHI | None listed |
| Nov 27, 2013 | B. Braun Medical, Inc. 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300
Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Terminated |
LHI | None listed |
| Nov 5, 2010 | B. Braun Medical Inc B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 bags per shipping box)
Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution ba Terminated |
LHI | None listed |
| Nov 5, 2010 | B. Braun Medical Inc B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box)
Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution ba Terminated |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.