Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns
Arrow International is recalling specific lots of 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 may be compromised, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Percutaneous Sheath Introducer Kits with Integral Hemostasis Valve/Side Port and Sharps Safety Features. The specific product code is ASK-09907-SB, which is recommended for use with 7 Fr. Catheters. The recall affects specific lot numbers: 13F17D0180, 13F17H0192, 13F17K0223, and 13F17K0555.
The recall is being conducted because product sterility may be compromised due to unsealed packaging. This issue poses a potential 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 the Americas. Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected kits.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
- 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: 13F17D0180 13F17H0192 13F17K0223 13F17K0555
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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