510(k) K101677 ยท FPA Set, Administration, Intravascular
HOSPIRA INFUSION BLOOD SETS
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Aug 11, 2010 |
| Received | Jun 15, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2014 | Hospira Inc. *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Terminated |
FPA | None listed |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage:
The CLAVE of the secondary port i Terminated |
FPA | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest Terminated |
BRZ | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 Terminated |
BRZ | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries sh Terminated |
BRZ | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 6004 Terminated |
BRZ | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Ri Terminated |
BRZ | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Terminated |
BRZ | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Terminated |
BRZ | None listed |
| Aug 5, 2013 | Hospira Inc. List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be di Terminated |
BRZ | None listed |
| Jul 25, 2012 | Hospira Inc. Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx Terminated |
FPA | None listed |
| Jan 19, 2012 | Hospira Inc. Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Terminated |
FPA | None listed |
| Nov 25, 2011 | Hospira Inc. Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administ Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.