Recall Z-2061-2016— Hospira Inc.

Name: FDA recall Z-2061-2016
Creator: U.S. Food and Drug Administration
Published: 2013-09-09

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-09-09, terminated 2016-12-06. It names one FDA 510(k) clearance: K052052. Product: *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.. Reason: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-09
Terminated: 2016-12-06
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K052052 — HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5Hospira, Inc.·cleared 2005-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

Reason for recall

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Data sourced from openFDA. This site is unofficial and independent of the FDA.