Arrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect
Arrow International Inc. is recalling Arrow-Flex Percutaneous Sheath Introducer Kits 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 is compromised, creating a risk of harm (infection) that has not yet been reported as an injury or illness, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of the Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port. The affected product codes are ASK-09903-UM, and the specific lot numbers involved are 13F17A0258, 13F17D0075, 13F17G0275, and 13F17L0615.
The recall was initiated because the product's 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 facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
- 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: 13F17A0258 13F17D0075 13F17G0275 13F17L0615
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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