Arrow AGB+ Multi-Lumen CVC Kit Recalled for Incorrect Lidstock Labeling
Arrow International Inc is recalling 745 units of the AGB+ Multi-Lumen CVC Kit because the lidstock label incorrectly lists the product code and catheter length.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect lidstock text) with no reported injuries or illnesses, fitting the criteria for a Low severity score (1) as it is a documentation/packaging issue.
Plain-English summary
Arrow International Inc is recalling 745 units of the Arrow AGB+ Multi-Lumen CVC Kit (Product Code CDC-42703-1A). The recall was initiated because the lidstock label incorrectly states the product code as CDC-45703-1A and lists a catheter length of 20cm. The banner card correctly identifies the product as CDC-42703-1A with a 16cm catheter length.
The affected product is a multi-lumen central venous catheter kit intended to provide venous access to central circulation via subclavian, jugular, and femoral veins. The product is not intended for long-term use exceeding 30 days. The discrepancy is limited to the lidstock labeling; the physical product matches the correct banner card specifications.
The recall covers units distributed nationwide in the United States. The specific lot number is 13F18L0759. Healthcare facilities and consumers should verify the product code and catheter length against the banner card to ensure they are using the correct device.
The recalled product
- Product
- Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 745
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 Number: 13F18L0759
Distribution
Distributed nationwide across the United States.
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