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 medical device defect that can lead to dural puncture, a significant injury requiring medical intervention (blood patch), which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Arrow International Inc. is recalling 343,105 units of the Epidural Catheterization Kit, Product Code MTO-09903-KU. The recall involves specific lots: 71F19B1406, 71F19E2026, and 71F19G1921. 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 providers and facilities should stop using the affected kits and contact Arrow International Inc. for further instructions on returns or replacements. Patients who have received epidural anesthesia using these kits should consult their healthcare provider if they experience symptoms consistent with dural puncture.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU
- 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: 71F19B1406 71F19E2026 71F19G1921
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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