Arrowgard Blue Central Venous Catheter Recalled for Labeling Error
Arrow International Inc. is recalling Arrowgard Blue and Blue Plus catheters because the packaging incorrectly lists an echogenic needle, which may not be present.
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 an FDA Class II recall involving a labeling error that could lead to procedural errors, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc. is recalling 4,285 units of Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheters. The recall is due to a labeling inconsistency on the product packaging.
The kit labeling states that it contains an "Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW" and a 5mL ArroW Raulerson Spring-Wire Introduction Syringe. However, the kit actually contains, and the label should state, an "Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW" and the same syringe. The source text notes that this inconsistency could affect clinical procedures if a clinician relies on the label to place the needle under x-ray guidance.
The affected units were distributed only to Michigan. The specific lot codes involved are MF2016829, RM2072044, RM2034076, RM2095792, RM2056629, RM3015571, and RM2069733. Clinicians and facilities should verify the contents of their kits against the correct specifications and contact the manufacturer for further instructions.
The recalled product
- Product
- Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 4,285
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)
- MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733
Distribution
Distributed in 1 state:
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