Arrow International Recalls TheraCath Epidural Catheterization Kits
Arrow International is recalling TheraCath 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 TheraCath Epidural Catheterization Kits, Product Code ASK-05001-SLR1. The recall involves specific lots: 23F18M0499, 23F19F0164, 23F19H0109, 23F19L0471, 23F19C0409, 23F19G0535, and 23F19K0082. The products were distributed to healthcare facilities in 36 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 was initiated because there is a potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures can result in dural puncture, a condition where the dura mater is accidentally punctured during the procedure. In some cases, patients may require a blood patch to treat the puncture.
Healthcare providers should stop using the affected kits and contact Arrow International Inc for further instructions on the recall process. Patients who have received these kits should consult their healthcare provider if they experience symptoms associated with dural puncture.
The recalled product
- Product
- TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
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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