Arrow Epidural Needle Kit Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 180 units of the Arrow EPIDURAL NEEDLE KIT SL-05500 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 classified as Low severity because it involves a documentation and labeling issue (incorrect expiration date on lidstock) with no reported injuries or illnesses, fitting the criteria for cosmetic defects or documentation issues.
Plain-English summary
Arrow International Inc. is recalling 180 units of the Arrow EPIDURAL NEEDLE KIT SL-05500. The recall was initiated because the product lidstock contains the incorrect expiration date for the product.
The affected units are identified by Lot Number 13F17H0053. The products were distributed nationwide and in 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 replacement.
The recalled product
- Product
- Arrow EPIDURAL NEEDLE KIT SL-05500
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 180
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: 13F17H0053
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.
See all 20 products in this recall →Related recalls
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