Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
Arrow International is recalling 343,105 Epidural Catheterization Kits because the included loss of resistance syringes may fail, potentially causing dural puncture.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect can result in dural puncture requiring a blood patch, which constitutes a significant injury report, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Arrow International Inc. is recalling 343,105 units of the Epidural Catheterization Kit, Product Code UR-05501-EXP. The recall involves specific lots: 71F19B0757, 71F19D1493, 71F19E2344, 71F19G2640, 71F19J0575, 71F19C0748, 71F19E0193, 71F19G1146, 71F19H2120, and 71F19K1689.
The recall is being conducted because there is a potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures could result in dural puncture, with some cases also requiring a blood patch. The FDA has classified this as a Class II recall.
The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these kits.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 343,105
Distribution
Part of a larger recall action
This product is one of 49 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 49 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
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · dural puncture
See all →- SevereArrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Kits
FDA (Devices) · 2020-02-19
- HighArrow International Recalls Epidural Catheterization Kits Due to Syringe Failures
FDA (Devices) · 2020-02-19
- SevereArrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
FDA (Devices) · 2020-02-19
- HighArrow International Recalls FlexTip Plus Epidural Catheterization Kits
FDA (Devices) · 2020-02-19
- SevereArrow International Recalls FlexTip Plus Epidural Catheterization Kits
FDA (Devices) · 2020-02-19