Arrow International Recalls Central Venous Catheter Kits Due to Hub Voids
Arrow International is recalling 310 units of Arrowg+ard Blue Plus Central Venous Catheterization Kits due to possible voids in the catheter hub that could lead to interlumen crossover.
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 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 agency classifies this as a Class II recall, and the defect (interlumen crossover in a central venous catheter) poses a significant risk of injury or serious health consequences, fitting the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Arrow International Inc is recalling 310 units of the Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. The recall is due to possible voids in the catheter hub, which could lead to an interlumen crossover. The product is intended to provide venous access to central circulation and protection against catheter-related bloodstream infections.
The affected product codes are ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM. The specific lot numbers involved are 13F16L0105, 23F16K0180, and 13F16L0199. The agency classifies this recall as Class II.
The product was distributed in the United States to New Jersey, Illinois, and Pennsylvania. Healthcare facilities and consumers should check their inventory for these specific product codes and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related…
- Manufacturer
- Arrow International Inc
- Affected units
- 310
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 (4)
- Product Codes ASK-45703-PRWJ1
- ASK-45703-PUAB1
- and ASK-45703-PUPM Lot # 13F16L0105
- 23F16K0180 and 13F16L0199
Distribution
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