510(k) K103224 ยท FPA Set, Administration, Intravascular
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Jan 7, 2011 |
| Received | Nov 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103224
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; Terminated |
FPA | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to H Terminated |
BRZ | None listed |
| Apr 19, 2011 | Hospira Inc. Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; Made in Costa Terminated |
KDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.