Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns
Hospira is voluntarily recalling 0.9% Sodium Chloride Irrigation bags due to possible leaking that compromises sterility.
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 a medical product, which meets the criteria for a Severe rating.
Plain-English summary
Hospira, Inc. is voluntarily recalling 98,084 units of 0.9% Sodium Chloride Irrigation, USP, 3000 mL. The product is identified by NDC 0409-7972-08 and includes lots 04-151-JT and 06-040-JT with an expiration date of 4/13.
The recall was initiated due to a lack of assurance of sterility caused by possible leaking bags. This defect poses a risk of contamination to the sterile solution.
The affected product was distributed nationwide, as well as in Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
- Manufacturer
- Hospira Inc.
- Category
- Drug — Sterile Irrigation
- Affected units
- 98,084
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)
- Lots #: 04-151-JT
- 06-040-JT
- Exp 4/13
Distribution
Part of a larger recall action
This product is one of 9 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.
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