Arrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion
Arrow International is recalling specific PICC kits because they may contain the wrong catheter type, potentially delaying patient treatment.
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 recall is classified as FDA Class II, but the source text explicitly states the issue causes a delay in treatment rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling 1,257 units of 4.5 Fr x 40 cm single-lumen PICC Kits (Product Code CDC-44041-VPS2) and 5.5 Fr double-lumen PICC Kits (Product Code CDC-44052-VPS2). The recall was initiated because the kits may contain the incorrect catheter. Specifically, kits intended to contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter, and vice versa.
The affected products were distributed to healthcare facilities in the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA. The source text does not specify the exact number of units distributed to each state or the specific facilities involved.
This issue may cause a delay in treatment while a replacement catheter is obtained. The source text does not report any injuries or illnesses associated with this recall. Healthcare providers should check their inventory for these specific product codes and contact Arrow International Inc for further instructions.
The recalled product
- Product
- 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 1,257
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)
- 23F18B0428
Distribution
Part of a larger recall action
This product is one of 2 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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