Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
Arrow International Inc. 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' rubric criteria.
Plain-English summary
Arrow International Inc. is recalling 343,105 units of the Epidural Catheterization Kit, Product Code MTO-05500-SU. The recall affects specific lots: 71F19D0624, 71F19E0717, 71F19F1173, 71F19F1768, and 71F19L0352.
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 facilities and consumers should check their inventory for the affected lot numbers and stop using the products if they match the recall criteria.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU
- 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: 71F19D0624 71F19E0717 71F19F1173 71F19F1768 71F19L0352
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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