Arrow International Recalls PICC Kits Due to Hub Tab Detachment
Arrow International Inc is recalling 12,157 units of various PICC and midline catheter kits because the peel-away component hub tabs may prematurely detach during use.
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 2/5 (Moderate).
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 source text explicitly states the issue does not pose a significant risk to the patient and only causes a delay in treatment, fitting the criteria for a voluntary precautionary recall with low risk of harm.
Plain-English summary
Arrow International Inc is recalling 12,157 units of ARROW PICC Kits, Midline Catheterization Kits, and related pressure injectable catheter products. The recall covers specific product codes distributed worldwide, including the United States and international locations such as Canada and Belgium.
The recall was initiated because the catheter peel-away component hub tabs may prematurely detach when a practitioner begins to peel apart the sheath body from the catheter. According to the source text, this issue does not pose a significant risk to the patient but may cause a delay of treatment when placing the catheter.
Healthcare providers and facilities that have received these products should stop using the affected kits and contact Arrow International Inc for further instructions. The affected products are used for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and other medical procedures.
The recalled product
- Product
- ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 12,157
Distribution
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Similar recalls
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