The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1036-2014·Announced 2014-02-05

Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

Hospira is recalling 27,780 bags of Heparin Sodium 2000 USP Units per 1000 mL due to a lack of assurance of sterility and potential leakage from the administrative port.

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 rubric specifies that FDA Class II recalls with potential for serious adverse health consequences (such as sterility failure in an IV drug) are rated as Severe (4).

Plain-English summary

Hospira Inc. is recalling 27,780 bags of Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection. The product is identified by Lot # 26-125-JT and has an expiration date of 8/14. The recall is being conducted due to a lack of assurance of sterility and the potential for leakage from the administrative port.

The affected product is a prescription-only intravenous medication distributed nationwide, including Puerto Rico. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should stop using the affected product and contact Hospira for instructions on return or disposal. Patients who have received this product should consult their healthcare provider if they have concerns or experience any adverse effects.

The recalled product

Product
HEPARIN SODIUM (HEPARIN SODIUM)
Brand
HEPARIN SODIUM
Manufacturer
Hospira Inc.
Category
Drug — Anticoagulant
Hazard
Affected units
27,780

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 #: 26-125-JT
  • Exp: 8/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same brand · HEPARIN SODIUM

Same manufacturer · Hospira Inc.

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Same hazard · sterility

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