Arrow Multi-Lumen CVC Kit Recalled for Expired Product Documentation Error
Arrow International Inc. is recalling 105 units of Arrow AGB + Multi-Lumen CVC Kits because shipping documentation listed an incorrect expiration date, though the product lidstock is correct.
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: This is a voluntary precautionary recall involving a documentation error where the primary safety check (lidstock) is correct, and no illnesses or injuries have been reported.
Plain-English summary
Arrow International Inc. is recalling 105 units of Arrow AGB + Multi-Lumen CVC Kits, Catalog Number CDC-42703-B1A. The recall was initiated because the product was shipped after its expiration date due to a system error. While the product lidstock correctly identifies the expiration date, the accompanying purchase order shipping documentation lists an incorrect date.
The affected units were distributed nationwide in California, Florida, North Carolina, and Rhode Island. The recall is precautionary; the agency notes that standard clinical practice involves checking the lidstock prior to use, which would likely prevent the use of expired product. However, if the lidstock is not checked, there is a potential for the use of expired product, which could compromise product functionality or sterility.
Healthcare facilities and consumers should check their inventory for this specific catalog number and lot code (23F16C0071). If found, the product should not be used and should be returned to the supplier or manufacturer for replacement.
The recalled product
- Product
- Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack…
- Manufacturer
- Arrow International Inc
- Affected units
- 105
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)
- 23F16C0071
Distribution
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