510(k) K033290 ยท FPA Set, Administration, Intravascular
TALON INFUSION SET, MODEL IP XXXX
| Applicant | Icu Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Apr 12, 2004 |
| Received | Oct 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | ICU Medical, Inc. Orbit and Orbit Micro
Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our d Terminated |
FPA | None listed |
| Jan 11, 2012 | ICU Medical, Inc. IV Start Kits
Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe. Terminated |
FPA | None listed |
| Aug 16, 2007 | ICU Medical, Inc. Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.