Z-2061-2016 Class II Terminated
FDA device recall Z-2061-2016 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: 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.
Distribution Pattern
US (Nationwide) Distribution
Code Information
***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 1) List Number: 19732-04-28; Lot Numbers: 114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2061-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026