Agency classClass IIOur severity:Severe FDA (Drugs)·D-0216-2019·Announced 2018-11-14

ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

ICU Medical is recalling 2,580,448 bags of 0.9% Sodium Chloride Injection because they may leak and lack assurance of 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for loss of sterility in an injectable product is a significant hazard.

Plain-English summary

ICU Medical Inc is voluntarily recalling 2,580,448 bags of 0.9% Sodium Chloride Injection, USP. The affected products are available in 250 mL, 150 mL, 50 mL, and 100 mL sizes and were distributed nationwide. The recall was initiated because the bags have the potential to leak, which creates a lack of assurance of sterility.

The specific lots involved are 84-011-JT, 85-014-JT, 84-015-JT, 84-016-JT, 84-005-JT, and 84-014-JT. These lots have expiration dates ranging from June 01, 2019, to January 01, 2020. The products are prescription-only and were manufactured by Hospira, Inc. in Lake Forest, IL.

Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical Inc for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
Manufacturer: ICU Medical Inc
Category: Drug — IV Fluids
Hazard: loss-of-sterility
leaking
Affected units: 2,580,448

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 (8)

Lots: a) 84-011-JT Exp. December 01
2019 and 85-014-JT Exp. January 01
2020
b) 84-015-JT Exp. December 01
2019
c) 84-016-JT Exp. June 01
d) 84-005-JT Exp. December 01
2019 and 84-014-JT Exp. December 01

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by ICU Medical 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 →

Same manufacturer · ICU Medical Inc

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Same hazard · loss of sterility