Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failures
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
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 is classified as FDA Class II. The hazard involves a risk of harm (dural puncture) where injury has not yet been reported as a widespread outcome, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc. is recalling 343,105 units of the Epidural Catheterization Kit, Product Code JC-05400-LB. The recall involves specific lots: 71F19B2180, 71F19E1142, 71F19F1082, 71F19H2578, 71F19E0149, 71F19F1081, 71F19G2551, and 71F19K1691.
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 may result in dural puncture, with some instances requiring a blood patch. The products were distributed to healthcare facilities in 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 should stop using the affected kits and contact Arrow International Inc. for further instructions on the recall process.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB
- Manufacturer
- Arrow International Inc
- 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.
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