FDA Device recall Z-2061-2016
*** 1) Product labeled in part: 19734-28
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of *** 1) Product labeled in part: 19734-28 by Hospira, citing intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2061-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-09 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hospira |
| Distribution | US |
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.
Identifiers
| code_info | ***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***…***** 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2061-2016%22
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