Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists
Arrow International is recalling 18,124 percutaneous sheath introducer kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves missing documentation rather than a physical defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 18,124 units of the Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath. The product is designed for venous access and catheter introduction to the central circulation and is intended for use with 7.5 - 8 Fr. catheters. The affected units are identified by the code ASK-29803-SJH 13F16K0136.
The recall was initiated because the products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist. These documents are tools intended to guide clinicians in the use of best practices during central line insertions. The agency has classified this recall as Class II.
The affected products were distributed nationwide. Clinicians and healthcare facilities should verify their inventory for the specific product code and stop using the affected kits. Users should contact Arrow International Inc for further instructions on the recall.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 18,124
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)
- ASK-29803-SJH 13F16K0136
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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