Arrow International Recalls Introducer Kits Due to Potential Sterility Compromise
Arrow International is recalling Introducer Kits and Arrow PSI Kits because packaging may not be completely sealed, potentially compromising sterility.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity rating involving potential sterility compromise without confirmed harm.
Plain-English summary
Arrow International is recalling specific Introducer Kits with Integral Hemostasis Valve/Side Port and Arrow PSI Kits. The recall is due to a defect where the packaging may not be completely sealed, which may compromise the sterility of the devices.
The affected products are identified by material numbers ASK-09803-WBH1, ASK-09903-KH, and CDC-09803-1A, under Device Listing E433883. A total of 27,485 units were distributed in the United States and 4,371 units were distributed internationally, with distribution patterns covering the U.S. (nationwide) and Canada.
Healthcare providers and consumers should stop using these products immediately. Users should contact Arrow International for instructions on how to return the affected units or obtain replacements.
The recalled product
- Product
- 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Introducer Kits
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 (3)
- Material number: ASK-09803-WBH1
- ASK-09903-KH
- CDC-09803-1A Device Listing E433883
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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