The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0281-2015·Announced 2014-12-03

Hospira Recalls Lactated Ringer's and 5% Dextrose Injection Bags

Hospira is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are rated as Severe (4). The potential for sterility loss in IV fluids is a significant safety hazard.

Plain-English summary

Hospira, Inc. is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL containers. The affected products are prescription-only and were distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands. The recall involves Lot # 34-134-JT and Lot # 34-166-JT, both with an expiration date of 10/15.

The recall was initiated due to a lack of assurance of sterility. The source text indicates a potential for punctures through the overwrap and primary container, which may result in IV bag leaks. This defect poses a risk to the sterility of the intravenous solution.

Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their inventory for the specific lot numbers and expiration dates listed above and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.
Manufacturer
Hospira Inc.
Category
Drug — IV Fluids
Hazard
Affected units
275,448

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)

  • Lot # 34-134-JT Exp. 10/15 Lot # 34-166-JT Exp. 10/15

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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