Arrow International Recalls Two-Lumen CVC Kits Due to Labeling Error
Arrow International is recalling 156 Two-Lumen CVC Kits because a portion of the packaging incorrectly identifies the catheter as 3-Lumen.
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 and involves a minor labeling error regarding the number of lumens, which fits the rubric for moderate severity involving labeling issues without reported injuries.
Plain-English summary
Arrow International, Inc. is recalling 156 units of its Two-Lumen CVC Kit with Blue Flex Tip Catheter. The recall is due to a labeling inconsistency on the product packaging. Specifically, one portion of the lidstock states that the kit contains a 3-Lumen catheter, while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
The affected products are identified by Catalog # AK-17702-CDC and Lot # RF2083258. These kits were distributed to facilities in Alabama, Pennsylvania, Connecticut, North Carolina, Virginia, Kansas, Rhode Island, Arizona, New Jersey, and Illinois.
Healthcare providers and consumers should check their inventory for this specific lot and catalog number. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with standard recall procedures.
The recalled product
- Product
- Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 156
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)
- Catalog # AK-17702-CDC
- lot # RF2083258
Distribution
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