Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
Arrow International Inc is recalling 343,105 Epidural Catheterization Kits because the included loss of resistance syringes may fail, potentially causing dural puncture.
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 recall is classified as FDA Class II and involves a medical device defect that can lead to dural puncture and the need for a blood patch, which aligns with the rubric criteria for significant injury or hospitalization reports.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit, Product Code UR-05501-FR1. The recall involves specific lots: 71F19B0757, 71F19D1493, 71F19E2344, 71F19G2640, 71F19J0575, 71F19C0748, 71F19E0193, 71F19G1146, 71F19H2120, and 71F19K1689.
The recall was initiated because there is the 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 FDA has classified this as a Class II recall.
The affected 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 listed lot numbers and stop using the affected kits.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1
- 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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