Arrow International Recalls ARROWg+ard Blue CVC Kits for Central Venous Access
Arrow International Inc is recalling ARROWg+ard Blue CVC Kits used for short-term central venous access. The recall affects 27,485 units distributed in the U.S. and 4,371 units internationally.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling ARROWg+ard Blue CVC Kits, which are medical devices intended to permit venous access to the central circulation. These kits are indicated for short-term (less than 30 days) central venous access for treatments requiring central venous access, including multiple infusions of fluids, medications, or chemotherapy, infusion of hypertonic or hyperosmolar fluids, frequent blood sampling, and central venous pressure monitoring.
The recall involves material numbers CDC-24301-1A and CDC-24306-1A. A total of 27,485 units were distributed in the United States and 4,371 units were distributed internationally. The distribution pattern includes nationwide distribution in the U.S. and Canada.
Healthcare facilities and consumers should stop using the affected ARROWg+ard Blue CVC Kits and contact Arrow International Inc for further instructions on the recall process.
The recalled product
- Product
- ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
- Manufacturer
- Arrow International Inc
- Hazard
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 (2)
- Material number: CDC-24301-1A
- CDC-24306-1A Device Listing D025398
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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