Arrow Recalls Walrus Arterial Embolectomy Catheters Due to Labeling Errors
Arrow International Inc is recalling 2,425 Walrus Arterial Embolectomy Catheters nationwide due to incorrect labeling.
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 and involves minor labeling errors without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 2,425 units of the Walrus Arterial Embolectomy Catheter. These medical devices are intended for use in removing arterial emboli. The recall is being conducted because of incorrect labeling of the products.
The affected catheters were distributed nationwide in the United States. The recall covers specific lot and batch numbers, including 14F15H0292, 14F15J0139, 14F15A0174, CF3016366, 14F14E0300, 14F15G0349, 14F15H0261, CF2079921, 14F15J0363, 14F14J0155, 14F15F0406, 14F15E0263, 14F15H0258, 14F15H0251, 14F15G0347, CF2125865, 14F15D0197, 14F15H0025, 14F15H0332, 14F15B0244, and 14F15G0348.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. The source text does not specify further instructions for consumers or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 2,425
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)
- Lot/Batch 14F15H0292
- 14F15J0139
- 14F15A0174
- CF3016366
- 14F14E0300
- 14F15G0349
- 14F15H0261
- CF2079921
- 14F15J0363
- 14F14J0155
- 14F15F0406
- 14F15E0263
- 14F15H0258
- 14F15H0251
- 14F15G0347. CF2125865
- 14F15D0197
- 14F15H0025
- 14F15H0332
- 14F15B0244
- 14F15G0348
Distribution
Distributed nationwide across the United States.
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