Device 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.
Z-2061-2016
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,920,932 units in total
- Official record key
device-enforcement:Z-2061-2016
Official wording
Reason: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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
Distribution pattern: US (Nationwide) Distribution
Derived failure modes
-
Unknown
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.