Arrow Central Venous Catheter Recall for Labeling Inconsistency
Arrow International is recalling 634,912 central venous catheter sets because the product label states 'contains no medication' while the insert indicates the product is medicated.
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 I, which typically indicates a low probability of adverse health consequences, and the issue is a labeling inconsistency rather than a physical defect or contamination.
Plain-English summary
Arrow International Inc is recalling 634,912 units of Arrow Two-Lumen Central Venous Catheterization Sets with Blue FlexTip ARROWgard Blue Catheter. The recall was initiated due to a labeling discrepancy where the product lidstock does not contain the chlorhexidine contraindication and includes the wording "contains no medication," whereas the product insert reflects the medicated status of the device.
The affected products were distributed worldwide, including the United States and numerous international markets. The recall covers various part numbers and specific lot numbers listed in the agency's documentation.
Healthcare providers and consumers should check their inventory for the specific part numbers and lot numbers identified in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or distributor in accordance with the recall instructions.
The recalled product
- Product
- Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 634,912
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 (20)
- Part numbers (PN) AD-24703 -- lots ZF0088927
- ZF0099619
- ZF0099893
- ZF0100764
- ZF0111386
- ZF0112205
- ZF1013500
- ZF1024535
- ZF1025078
- ZF1036034
- ZF1036293
- ZF1047553
- ZF1068055
- ZF1079398
- ZF1080286
- ZF1091018
- ZF1102643
- ZF1103235
- ZF1113530
- ZF1114129
Distribution
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