Home / Recalls / Hospira Inc. / Z-2062-2016

Z-2062-2016 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-2062-2016 was initiated by Hospira Inc. on Sep 9, 2013 and is designated Class II. Reason for recall: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. The recall status is terminated (terminated Dec 6, 2016). Affected quantity: 3,920,932 units in total.

Recall Details

Product Type: Devices
Report Date: Jul 6, 2016
Initiation Date: Sep 9, 2013
Termination Date: Dec 6, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,920,932 units in total

Product Description

*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 6) 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.

Distribution Pattern

US (Nationwide) Distribution

Code Information

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2062-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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