Arrow Arterial Catherization Kit Recalled for Incorrect MR Labeling
Arrow International is recalling 80 kits due to a lidstock label error that displays an MR Conditional symbol instead of MR Unsafe.
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 recall is classified as FDA Class II, but the source text identifies the issue as a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling defect.
Plain-English summary
Arrow International Inc is recalling 80 units of the Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm (Product Code: ASK-04020-PMC). The recall is limited to Lot/Batch Number PMC 23F19H0224, which was distributed to South Carolina.
The recall was initiated because the lidstock label incorrectly displays an MR (Magnetic Resonance) Conditional symbol instead of an MR Unsafe symbol for a component of the kit. This labeling error could lead to incorrect safety assessments regarding the use of the device in magnetic resonance imaging environments.
Healthcare facilities and consumers who have this specific product should stop using it and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial…
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 80
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/Batch Number: PMC 23F19H0224
Distribution
Distributed in 1 state:
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