Medline 111 Gravity Set with Needle Free Y-Sites engineering sample recall
BD Switzerland SARL is recalling a Medline 111 Gravity Set with 3 Needle Free Y-Sites (Catalog Number SAM2461, Lot 25X445) because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or confirmed use on patients; the hazard is that unapproved engineering samples were inadvertently distributed, making this a precautionary recall that warrants a Moderate classification.
Plain-English summary
BD SWITZERLAND SARL is recalling Medline 111 Gravity Set with 3 Needle Free Y-Sites, Catalog Number SAM2461, Reference DYNDTN0555, Lot Number 25X445. These devices are engineering samples labeled "Not for Human Use" that were inadvertently shipped to the U.S. market.
Engineering samples are not intended for use on patients and may not meet the same safety and performance standards as finished medical devices approved for distribution. The devices distributed in this recall are categorized as FDA Class II.
Affected consumers in Illinois should not use these devices. Consult with your healthcare provider or contact the manufacturer for instructions on product return or disposal.
The recalled product
- Product
- MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
- Manufacturer
- BD SWITZERLAND SARL
- Affected units
- 50
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)
- Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
Distribution
Distributed in 1 state:
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