Arrow JACC IV Catheters Recalled Due to Potential Sterility Compromise
Arrow International Inc. is recalling 416,055 ARROW JACC IV catheters because unsealed packaging may have compromised product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, posing a risk of infection. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not an FDA Class I recall.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of ARROW JACC with Chlorag+ard Technology intravenous catheters. The recall involves product codes JR-42063-HPHNM and JR-42563-HPHNM, specifically lot numbers 13F17C0327 and 13F17F0099. The products were distributed nationwide in the United States and in numerous international markets, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Middle East.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect poses a risk of infection if the non-sterile products are used for intravenous access. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and distributors should check their inventory for the specific product codes and lot numbers listed above. If these products are found, they should be removed from use and returned to Arrow International Inc. according to the company's instructions. Patients who have received these catheters should contact their healthcare provider if they experience signs of infection.
The recalled product
- Product
- ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 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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