Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information
Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.
What this means for you
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 the hazard involves missing documentation (lot number, expiration date, UDI) rather than a direct physical defect or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Arrow International Inc is recalling 420 units of the ARROWg+ard Blue PLUS catheter, Catalog Number ASK-45854-NG. The recall affects specific lots distributed in Florida, United States. The affected lot numbers are 23F16H0744, 23F16J0072, and 23F17B0781.
The recall was initiated because certain lots may be missing critical information at the bottom of the lid, including the lot number, expiration date, and Unique Device Identification (UDI) information. The ARROWg+ard Blue PLUS catheter is intended to provide venous access to central circulation and protection against catheter-related bloodstream infections, but it is not indicated for long-term use exceeding 30 days.
Healthcare providers and facilities that have received these specific lots should stop using the affected products and contact Arrow International Inc for further instructions. Consumers should not use these devices if they are found in a home setting and should contact their healthcare provider for guidance.
The recalled product
- Product
- ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against cat
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Affected units
- 420
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 (3)
- Lot Numbers: 23F16H0744
- 23F16J0072
- 23F17B0781
Distribution
Distributed in 1 state:
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