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.
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 3/5 (High).
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.
See all 76 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighArrow PICC Kit Recall Due to Potential Sterility Seal Failure
FDA (Devices) · 2018-04-18
- ModerateArrow JACC Medical Device Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2019-06-26
- HighArrow Recalls PICC Kits Due to Potential Packaging Seal Defects
FDA (Devices) · 2017-06-21
- ModerateArrow JACC Medical Device Recalled for Incorrect Expiration Date
FDA (Devices) · 2019-06-26
- HighArrow International Recalls Central Venous Access Kits Due to Sterility Concerns
FDA (Devices) · 2018-04-18
- ModerateArrow JACC Central Catheter Recalled for Incorrect Expiration Date
FDA (Devices) · 2019-06-26