The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0287-2015·Announced 2014-12-03

Hospira Recalls Sterile Water for Injection Due to Sterility Concerns

Hospira is recalling 153,504 bags of Sterile Water for Injection due to potential punctures that may compromise sterility and cause leaks.

The agency’s classification

FDA (Drugs): 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury.

Plain-English summary

Hospira Inc. is recalling 153,504 bags of Sterile Water for Injection, USP, 1000 mL container (NDC 0409-7990-09). The recall is due to a lack of assurance of sterility, specifically the potential for punctures through the overwrap and primary container which may result in IV bag leaks.

The affected product is identified by Lot# 36-084-JT with an expiration date of 12/15. The product was distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
Manufacturer
Hospira Inc.
Category
Drug — Injectable
Hazard
Affected units
153,504

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 (2)

  • Lot# 36-084-JT
  • Exp.12/15

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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