Arrow Pressure Injectable PICC Catheter Recall Due to Incorrect Length
Arrow International Inc. is recalling 789 units of Arrow Pressure Injectable PICC catheters because they contain a 40cm catheter instead of the required 50cm catheter.
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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a packaging error resulting in the wrong catheter length, which is a significant defect but does not involve a high-risk pathogen or immediate life-threatening hazard like a structural failure or toxic contamination.
Plain-English summary
Arrow International Inc. is recalling 789 units of Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet, catalogue number CDC-35052-VPS. The recall is due to a packaging error where the kits contain a 40cm catheter instead of the correct 50cm catheter.
The affected product is a peripherally inserted central catheter (PICC). The distribution was nationwide, including the states of Arizona, Tennessee, Florida, Georgia, and California. The specific lot number for the recalled units is 23F14A0375.
Healthcare providers and consumers should stop using the affected kits and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 789
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)
- lot #23F14A0375
Distribution
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