Agency classClass IIOur severity:High FDA (Devices)·Z-2044-2019·Announced 2019-07-31

Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Defect

Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

The agency’s classification

FDA (Devices): 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a compromised sterility barrier, which poses a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Cardinal Health 200, LLC is recalling Monoject 201 Vet Pak Hypodermic Needles, 20 ga x 1-1/2" (Item code: 8881201498). The recall is due to a manufacturing defect in the cartridge component that could compromise the sterility barrier of the product.

The affected product is identified by Lot Number 905611. The recall covers distribution in the United States and foreign markets including Australia, Belgium, Canada, Denmark, Finland, Great Britain, Ireland, and the Netherlands.

This is an FDA Class II recall. Users should stop using the affected needles and contact Cardinal Health for further instructions.

The recalled product

Product: Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Hypodermic Needles
Hazard: sterility-compromise
infection-risk

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 (1)

Lot Number: 905611

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · sterility compromise