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 involves a Class II medical device with a risk of dural puncture requiring a blood patch, which constitutes a significant injury risk under the rubric.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit, Product Code ALZANO-05400-B. The recall involves specific lots: 71F19B0681, 71F19C0035, 71F19D2827, 71F19F2028, 71F19H1633, and 71F19K1574. 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 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 FDA has classified this as a Class II recall.
Healthcare facilities and consumers who have these specific kits should stop using them and contact Arrow International Inc for further instructions on return or replacement.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B
- 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: 71F19B0681 71F19C0035 71F19D2827 71F19F2028 71F19H1633 71F19K1574
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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