# K101677: Hospira Infusion Blood Sets

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Aug 11, 2010 after 57 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 13 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030467 (2003). 4 ancestors in all.
30 later devices descend from it; 8 cite it directly.
5 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063239: Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526, Hospira, Inc. (2006) Summary page 1.
- K030002: Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual W/Conv Pin & Cap Port; Lifeshield LF Macrobore Ext., Abbott Laboratories (2003) Summary page 1.
- K780880: Y-Type Blood Set, Abbott Laboratories (1978) Summary page 1.
- (no number) Hospira Administration Blood Sets with Manual Blood Pump: named in the summary without a submission number

## Most influential descendants
- K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal (2012), 19 descendants of its own
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (2015), 9 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own
- K142974: Extension Sets (2015), 4 descendants of its own

## Recalls of this device
- Oct 25, 2013 · Class II · Z-1126-2014: Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
- Sep 9, 2013 · Class II · Z-2060-2016: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
- Apr 1, 2013 · Class I · Z-1850-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Apr 1, 2013 · Class I · Z-1853-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Apr 1, 2013 · Class I · Z-1854-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Apr 1, 2013 · Class I · Z-1857-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Apr 1, 2013 · Class I · Z-1852-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Apr 1, 2013 · Class I · Z-1858-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Apr 1, 2013 · Class I · Z-1851-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Apr 1, 2013 · Class I · Z-1855-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Jul 13, 2012 · Class II · Z-2075-2012: The float valve in the burette sticks to the burette wall and does not open or close properly.
- Jan 12, 2012 · Not classified · Z-0817-2012: Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container.
- Nov 10, 2011 · Not classified · Z-0292-2012: The float valve in the burette sticks to the burette wall and does not open or close properly.

## Indications for use
Hospira Administration sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system.

Source page: https://510kreport.com/device/K101677
Methodology: https://510kreport.com/methodology