PlainRecalls
FDA Devices Moderate Class II Terminated

*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy second

Reported: July 6, 2016 Initiated: September 9, 2013 #Z-2058-2016

Product Description

*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 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.

Details

Recalling Firm
Hospira Inc.
Units Affected
1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units
Distribution
US (Nationwide) Distribution
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled? ▼
*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 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.. Recalled by Hospira Inc.. Units affected: 1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units.
Why was this product recalled? ▼
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2058-2016.

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