ClearanceBrief
510(k) K101677 ยท FPA Set, Administration, Intravascular

HOSPIRA INFUSION BLOOD SETS

ApplicantHospira, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Aug 11, 2010
ReceivedJun 15, 2010
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K101677

DateFirm and productCodeLinked 510(k)
Mar 6, 2014Hospira 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
FPANone listed
Sep 9, 2013Hospira 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
FPANone listed
Aug 5, 2013Hospira 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
BRZNone listed
Aug 5, 2013Hospira 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
BRZNone listed
Aug 5, 2013Hospira 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
BRZNone listed
Aug 5, 2013Hospira 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
BRZNone listed
Aug 5, 2013Hospira 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
BRZNone listed
Aug 5, 2013Hospira 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
BRZNone listed
Aug 5, 2013Hospira 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
BRZNone listed
Aug 5, 2013Hospira 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
BRZNone listed
Jul 25, 2012Hospira 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
FPANone listed
Jan 19, 2012Hospira 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
FPANone listed
Nov 25, 2011Hospira 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
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.