Device product
*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; 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-2060-2016
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-2060-2016
Official wording
Reason: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Code information: ***** CANADA DISTRIBUTION ***** *** 1) List Number 14220-28-01
Distribution pattern: US (Nationwide) Distribution
Derived failure modes
-
Unknown
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.