Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
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
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 risk of dural puncture requiring a blood patch, which constitutes a significant injury report or risk of significant injury, meeting the criteria for a Severe (4) rating.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit, Product Code AT-05501-LEO. The recall involves specific lots: 71F19B0740, 71F19C1369, 71F19G1023, 71F19J1434, 71F19C0033, 71F19E1660, and 71F19H1350. The products were distributed to 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 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 instances requiring a blood patch.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these kits if they match the recalled lots. Consumers are not typically the end-users of this medical device, but patients who have received epidural anesthesia using these kits should contact their healthcare provider if they experience symptoms consistent with dural puncture.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
- 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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