Cardinal Health Monoject Sterile Syringes Recalled for Manufacturing Change
Cardinal Health is recalling Monoject sterile syringes due to manufacturing changes. The recall affects Luer-Lock and Enteral syringe models distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I classification for a medical device indicates a significant regulatory concern, as Class I recalls are reserved for products where failure or malfunction could cause serious adverse health consequences or death. However, no specific illnesses, injuries, or reported adverse events are documented in the source text, preventing a Critical classification.
Plain-English summary
Cardinal Health Monoject sterile syringes in multiple sizes are subject to a product removal. The recall affects Luer-Lock syringes (1, 3, 6, 12, 20, 35, and 60 mL) and Enteral syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL).
The removal was initiated due to changes in manufacturing and rebranding efforts. Cardinal Health expanded its previous correction action to a full removal of affected products.
The recalled products were distributed nationwide in the United States and Canada. Specific lot numbers and identification codes (UDI) have been provided to assist in identifying affected units.
Consumers and healthcare facilities with these syringes should contact Cardinal Health for instructions regarding the return or replacement of affected products.
The recalled product
- Product
- Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
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 (20)
- UDI/DI 50192253033517 (Case)
- 20192253033516 (Box)
- 10192253033519 (Each)
- Lot Numbers: 230201
- 230202
- 221201
- 221202
- 230203
- 230204
- 230205
- 230206
- 230208
- 230209
- 230210
- 230211
- 230212
- 230213
- 230214
- 230215
- 230216
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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.
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