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 medical device defect that can lead to dural puncture and the need for a blood patch, which constitutes a significant injury report consistent with the 'Severe' criteria for FDA Class II recalls.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit, Product Code BE-05400-DCSHO. The recall covers specific lots: 71F19C0983, 71F19D0315, 71F19E1828, 71F19H1445, 71F19J1822, and 71F19K1828.
The recall was initiated 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, 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 should check their inventory for the affected lot numbers and discontinue use of these kits.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO
- 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: 71F19C0983 71F19D0315 71F19E1828 71F19H1445 71F19J1822 71F19K1828
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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