Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage
Hospira is recalling specific PlumSet IV administration sets because intravenous fluid may leak at the CLAVE secondary port.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential leak in an IV administration set, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hospira Inc. is recalling specific lots of LIFESHIELD PlumSet IV administration sets. The affected products include the Plum Y-Type Blood Set, Primary PlumSet with CLAVE Port and 2 CLAVE Y-Sites, and Primary PlumSet with CLAVE Port and CLAVE Y-Site. These devices are used for intravenous infusions, with the CLAVE secondary port allowing for concurrent or piggyback infusion modes.
The recall is being conducted because intravenous fluid may leak at the CLAVE secondary port of the affected sets. This defect could compromise the integrity of the infusion system. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The recall covers units distributed nationwide in the United States, as well as units distributed in foreign markets. Specific list numbers and lot numbers are identified in the official recall documentation. Consumers and healthcare providers should stop using the affected lots and contact Hospira Inc. for instructions on return or replacement.
The recalled product
- Product
- *** 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
- Manufacturer
- Hospira Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- ***** US DISTRIBUTION ***** *** 1) List Number: 14212-04-28
- Lot Numbers: 962235H
- 030565H
- 030575H
- 081425H
- 090515H
- 100905H
- 100915H
- 102255H
- 102265H
- 122515H
- 122525H
- 143405H
- 152655H
- 152665H
- 152675H
- 161375H
- 161385H
- 161395H
- 170955H
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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