Arrow International Recalls Spring Wire Guide Introducer Needles Due to Packaging Defect
Arrow International is recalling Spring Wire Guide Introducer Needles 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the hazard is compromised sterility, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Spring Wire Guide Introducer Needles, product codes AN-04320 and AN-04418. The recall is due to a defect where unsealed packaging may compromise the sterility of the medical devices.
The affected products were distributed nationwide in the United States and in numerous international locations, including Australia, Canada, and the United Kingdom. Specific lot numbers for product code AN-04320 include 13F17A0131, 13F17B0101, 13F17B0320, 13F17D0234, 13F17F0242, 13F17H0488, 13F17J0454, and 13F17M0003. Lot numbers for product code AN-04418 include 13F17F0738 and 13F17J0445.
Healthcare providers and consumers should stop using these products and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Needles
- 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 (8)
- Lot Numbers: Product code AN-04320: 13F17A0131
- 13F17B0101
- 13F17B0320
- 13F17D0234
- 13F17F0242
- 13F17H0488
- 13F17J0454
- 13F17M0003 Product code AN-04418: 13F17F0738 and 13F17J0445
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.
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