The Recall Desk
HighFDA (Devices)·Z-2046-2019·Announced 2019-07-31

Cardinal Health Recalls Monoject 201 Vet Pak Hypodermic Needles

Cardinal Health is recalling specific lots of Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the product's sterility barrier.

What this means for you

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 and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Cardinal Health 200, LLC is recalling Monoject 201 Vet Pak Hypodermic Needles, 18 ga x 1-1/2, Item code 8881201548. The recall affects lot numbers 904219, 904220, and 907710. The product was distributed nationwide and in foreign markets including Australia, Belgium, Canada, Denmark, Finland, Great Britain, Ireland, and the Netherlands.

The recall was initiated because a manufacturing defect was found in the cartridge component. This defect could compromise the sterility barrier of the product. The agency has classified this as a Class II recall.

Users of the affected products should stop using them and contact Cardinal Health 200, LLC for further instructions.

The recalled product

Product
Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548

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)

  • Lot Number: 904219
  • 904220
  • 907710

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 →