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
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 describes the risk as 'potential' and does not report specific instances of injury or death, 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 BE-05400-DCHH. The recall involves specific lots: 71F19D0610 and 71F19G2151. The products were distributed to hospitals and healthcare facilities in 36 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 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, a condition where the protective covering of the spinal cord is accidentally pierced. In some cases, this complication may require a blood patch to resolve.
Healthcare providers and consumers should stop using the affected kits immediately. Users should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be quarantined and returned to the manufacturer or disposed of according to local regulations. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH
- 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: 71F19D0610 71F19G2151
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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