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 and involves a risk of dural puncture, a significant medical complication, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit (Product Code AT-05501-LIN). The recall involves specific lots: 71F19C1431, 71F19H1811, and 71F19K1515. The affected products were distributed to healthcare facilities in 37 US states, including 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.
The recall was initiated 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, a condition where the dura mater is accidentally punctured during the procedure. In some cases, patients who experience this complication may require a blood patch to treat the resulting condition.
Healthcare providers and consumers should stop using the affected kits immediately. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots: 71F19C1431 71F19H1811 71F19K1515
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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