Recall Z-2060-2016— Hospira Inc.
Class II · Terminated
Class II FDA medical device recall by Hospira Inc., initiated 2013-09-09, terminated 2016-12-06. It names one FDA 510(k) clearance: K101677. 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.. Reason: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets..
- Recalling firm
- Hospira Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-09
- Terminated
- 2016-12-06
- Firm location
- Lake Forest, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
*** 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.
Reason for recall
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Data sourced from openFDA. This site is unofficial and independent of the FDA.