Cardinal Health Recalls MONOJECT Hypodermic Needles Due to Detachment Risk
Cardinal Health is recalling MONOJECT Standard Hypodermic Needles because the needle may detach from the cartridge, posing a risk of needle stick injury.
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 and involves a risk of needle stick injury from a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 519,676 units of the Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". The affected product is identified by Item Code 8881250248 and includes Lot Numbers 011144 and 011145. The recall was initiated due to a potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed.
If the needle is not securely seated, it can fall out of the sheath and cause the unused needle to project out of the cartridge. This malfunction results in a risk of a needle stick or puncture from the clean, unused needle. The agency has classified this recall as Class II.
The affected units were distributed in the United States, Australia, and Canada. Users should stop using the affected needles and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 519,676
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: 011144 Expanded Recall 11/4/20: Lot Number: 011145
Distribution
Distributed nationwide across the United States.
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