The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0278-2015·Announced 2014-12-03

Hospira Recalls Potassium Chloride IV Bags Due to Sterility Concerns

Hospira is recalling 836,460 bags of Potassium Chloride IV solution 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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk scenarios.

Plain-English summary

Hospira, Inc. is recalling 836,460 bags of Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container. 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 # 34-017-JT (Exp. 10/15) and Lot # 35-100-JT (Exp. 11/15). The product was distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands.

Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not used. Patients who have received this product should contact their healthcare provider for guidance.

The recalled product

Product
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
Manufacturer
Hospira Inc.
Category
Drug — IV Solution
Hazard
Affected units
836,460

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 (3)

  • Lot # 34-017-JT
  • Exp. 10/15 Lot # 35-100-JT
  • Exp. 11/15

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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