Agency classClass IIOur severity:Severe FDA (Drugs)·D-627-2013·Announced 2013-07-10

Baxter Recalls Lidocaine Injection Due to Sterility Concerns

Baxter Healthcare is recalling specific lots of Lidocaine Hydrochloride and 5% Dextrose Injection due to a manufacturing defect that may compromise 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 classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Baxter Healthcare Corp. is recalling specific lots of Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL. The recall is due to a lack of assurance of sterility caused by a manufacturing issue during the sealing of the closure assembly at the administration port.

The defect may result in potential leakage at the administration port. The affected product is identified by Product code 2B0973, P279935, with an expiration date of 7/13. The distribution pattern for this recall is nationwide and Puerto Rico.

Healthcare providers and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or the recalling firm.

The recalled product

Product: Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
Manufacturer: Baxter Healthcare Corp.
Category: Drug — Injectable Medication
Hazard: sterility
leakage

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 #: Product code 2B0973: P279935
Exp 7/13

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 6 recalled by Baxter Healthcare Corp. 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 6 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · sterility