The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2060-2016·Announced 2016-07-06

Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage

Hospira is recalling PlumSet IV administration sets because intravenous fluid may leak at the secondary port. The recall covers 3,920,932 units distributed in the US and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as fluid leakage in a medical device) are categorized as Severe (Score 4), especially given the rule that FDA Class I/II classifications generally warrant a score of 4 or higher if not explicitly low-risk.

Plain-English summary

Hospira Inc. is recalling specific lots of PlumSet IV administration sets. The recall involves 3,920,932 units that were distributed nationwide in the United States and in Canada. The affected products are identified by List Number 14220-28 and are described as Y-type blood sets with a 200-micron filter, CLAVE port, and non-DEHP composition.

The recall was initiated because intravenous fluid may leak at the CLAVE secondary port of the administration sets. This port is designed to allow for concurrent and piggyback infusion modes using a syringe or secondary IV infusion set. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and consumers should stop using the affected IV administration sets immediately. Users should check their inventory for the specific list numbers and product descriptions mentioned in the recall notice. For further information or to report adverse events, users should contact Hospira Inc. or the FDA.

The recalled product

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…
Manufacturer
Hospira Inc.
Category
Medical Device — IV Administration Sets
Hazard
Affected units
3,920,932

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 (1)

  • ***** CANADA DISTRIBUTION ***** *** 1) List Number 14220-28-01

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.

See all 5 products in this recall →

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