Arrow International Recalls 0.2 Micron Flat Epidural Filters Due to Packaging Issues
Arrow International Inc is recalling 0.2 Micron Flat Epidural Filters because unsealed packaging may compromise product sterility.
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 the hazard is a potential sterility compromise due to packaging, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported injuries.
Plain-English summary
Arrow International Inc is recalling 416,055 units of 0.2 Micron Flat Epidural Filters (Product Code: EF-05500). The recall is due to a defect where product sterility may be compromised by unsealed packaging.
The affected products are distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom. Specific lot numbers involved in this recall are 13F17D0240, 13F17G0371, and 13F17K0408.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. Consumers should contact their healthcare provider or the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- 0.2 Micron Flat Epidural Filter; Product Code: EF-05500
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
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 Numbers: 13F17D0240 13F17G0371 13F17K0408
Distribution
Part of a larger recall action
This product is one of 76 recalled by Arrow International Inc 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.
See all 76 products in this recall →Related recalls
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