Arrow International Recalls 9 Fr. Radiopaque Polyurethane Sheath Due to Packaging Defect
Arrow International Inc is recalling 416,055 units of 9 Fr. Radiopaque Polyurethane Sheath/Dilator 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 medical device where sterility may be compromised, creating a risk of infection (harm) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port. The product is intended for use with 7-8 Fr. Catheters and the Arrow Percutaneous Introducer System. The specific product code is SS-09903-S, and the affected lot number is 13F17H0405.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.
The affected products were distributed nationwide in the United States and in numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and South America. Healthcare providers and facilities should stop using the affected lots and contact Arrow International Inc for further instructions on returns or replacements.
The recalled product
- Product
- 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- 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: 13F17H0405
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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