Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Sterility Concerns
Arrow International Inc. is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.
What this means for you
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 is classified as FDA Class II and involves a risk of harm (infection due to compromised sterility) without reported 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 Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath. The recall involves specific product codes ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1, which are designed for use with 7.5 - 8 Fr. catheters. The affected products were distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.
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 agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers should stop using the affected products immediately. Users should check their inventory for the specific product codes and lot numbers listed in the official recall notice. Affected units should be returned to Arrow International Inc. or disposed of according to local regulations for medical waste.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- Affected units
- 416,055
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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