Arrow Epidural Needle Component Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 1,839 units of Arrow Epidural Needle Component AN-05505 because the product lidstock contains the incorrect expiration date.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (incorrect expiration date on lidstock) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Arrow International Inc is recalling 1,839 units of Arrow Epidural Needle Component AN-05505. The recall was initiated because the product lidstock contains the incorrect expiration date for the product.
The affected lots are 13F18H0836, 13F17L0441, and 13R17L0441. The products were distributed nationwide and to foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Arrow EPIDURAL NEEDLE COMPONENT AN-05505
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 1,839
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 Number: 13F18H0836 13F17L0441 13R17L0441
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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.
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