Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failures
Arrow International is recalling 343,105 epidural catheterization kits because the included 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' rubric criteria.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit, Product Code DE-05400D-BO. The recall involves specific lots: 71F19D2769, 71F19H0716, and 71F19K1690.
The recall is being issued because there is 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 instances requiring a blood patch.
The products were distributed to the following US states: 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 providers and patients should check their inventory and records for the affected lot numbers and discontinue use of these kits.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO
- 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: 71F19D2769 71F19H0716 71F19K1690
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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