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.
What this means for you
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 ci
- 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:
Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02