Arrow Central Venous Catheter Recalled for Incorrect Lidstock Labeling
Arrow International is recalling 380 units of its Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) due to incorrect product code and name listed on the package lidstock.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA Class I classification requires a minimum severity score of 4 per the assessment rubric. No illnesses or injuries have been reported; however, the labeling error on a medical device creates potential for device misidentification and clinical misuse.
Plain-English summary
Arrow International Inc. is recalling 380 units of the Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) distributed in the United States.
The recall was initiated following reports that the product code and product name were incorrectly listed on the lidstock of the affected kits.
The recalled product
- Product
- Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- Affected units
- 380
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)
- Batch/Lot number 13F22L0806
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by ARROW INTERNATIONAL Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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