Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
Arrow International is recalling 343,105 epidural catheterization kits because the included 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 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 constitutes a significant injury risk.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit, Product Code FR-05501-10. The recall involves specific lots: 71F19B1457, 71F19D1662, 71F19G0145, 71F19H2708, 71F19K2670, 71F19C1527, 71F19E1145, 71F19G2429, 71F19J1367, 71F19C2577, 71F19E2862, 71F19H1833, and 71F19K0948.
The FDA has classified this as a Class II recall. The recall is due to the 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 requiring a blood patch.
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 facilities and consumers should check their inventory for the affected lot numbers and discontinue use of these kits.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10
- 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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