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 consistent with the Severe severity criteria.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit (Product Code BE-080180-BXL). The recall is due to 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 cases requiring a blood patch. The affected lots are 71F19B0729, 71F19E2327, 71F19G1496, 71F19J1005, 71F19C1089, 71F19F0733, and 71F19H0793.
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. Healthcare facilities should stop using the affected kits and contact Arrow International for instructions on return or replacement.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL
- 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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